Lumen reinforcement and anchoring system

ABSTRACT

A tissue wall of a biological lumen may be reinforced by embedding a material or structure into the tissue wall. The reinforcement material or structure may embed by application of outwardly directed force along an interior side of the tissue wall, threading, or injection. The reinforcement material or structure may act as an embedded scaffold that limits expansion or contraction of the tissue wall to pushing or pulling forces. An anchor device, such as a medical device, may anchor to the reinforced portion of the tissue wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. Pat.Application No. 16/747,715, filed Jan. 21, 2020, now U.S. Pat. No.11,491,038, which is a continuation-in-part of U.S. Pat. Application No.16/046,592, filed Jul. 26, 2018, both of which are incorporated hereinby reference in their entirety.

TECHNOLOGY FIELD

The present disclosure is directed to biological lumen reinforcement andanchoring systems and methods of anchoring devices within a biologicallumen. The present disclosure is further directed to methods forreinforcing a tissue wall defining a biological lumen.

BACKGROUND

Medical devices may be implanted in biological lumens. Current surgicalprocedures for anchoring such devices include utilizing hooks topuncture through the wall of the lumen or otherwise internally anchoringthe device via interaction external to the lumen. Such procedures,however, tend to be more complicated and present higher risk of negativeoutcomes and trauma to the patient. Implanted medical devices may alsobe subject to pushing or pulling forces due to normal function of thelumen or the device. These forces may result in anchored hooks tearingthe tissue wall, causing further trauma and migration of the device froma target site. Improved techniques for anchoring an implanted medicaldevice are needed.

SUMMARY

In one aspect, a method of reinforcing a tissue wall of a biologicallumen includes embedding a reinforcement material or structure into aportion of the tissue wall.

In various embodiments, the reinforcement material or structure mayinclude an embedment device having a body. Embedding the reinforcementmaterial or structure comprises delivering the embedment device into thelumen and applying outwardly directed force along an interior side ofthe tissue wall to embed the body therein.

In one example, the body of the embedment device has a cross-sectiondimension greater than a corresponding cross-section dimension of thelumen to therein apply the outwardly directed force along the interiorside of the tissue wall. The cross-section dimension of the body may beless than a corresponding cross-section dimension of the tissue wall andcorresponding lumen, taken from exterior sides of the tissue wall, suchthat the body does not migrate to an exterior side of the tissue wall.The body of the embedment device may include a wire coil or a wire mesh.

In another example, the body of the embedment device comprises anexpandable tube. The expandable tube may be expandable or biased toobtain a cross-section dimension greater than a correspondingcross-section dimension of the lumen to therein apply the outwardlydirected force along the interior side of the tissue wall. Theexpandable tube may include a wire mesh or coil.

In one example, the body comprises a wire mesh. The wire mesh mayinclude one or more physical blocks extending between adjacent openingsto prevent migration of the body to an exterior side of the tissue wall.

In another example, the body of the embedment device has an embeddingconformation and an embedded conformation. The body may apply theoutwardly directed force in the embedding conformation and discontinuesapplication of the outwardly directed force in the embeddedconformation. In the embedded conformation, a cross-section dimension ofthe body may be less than a corresponding cross-section dimension of thetissue wall and corresponding lumen, taken from exterior sides of thetissue wall, such that the body does not migrate to an exterior side ofthe tissue wall.

In another example, applying the outwardly directed force along aninterior side of the tissue wall comprises compressing the reinforcementmaterial or structure against the interior side of the tissue wall.Compressing the reinforcement material or structure against the interiorside of the tissue wall may include positioning an inflatable devicewithin the lumen and inflating the inflatable device such that theinflatable device obtains a cross-section sufficient to compress thereinforcement material or structure against the interior side of thetissue wall. In another example, the body includes one or more outwardlydirected projections configured to penetrate, e.g., puncture, thetissue, wherein the projections are dimensioned to not puncture anexterior side of the tissue wall. In one embodiment, the projections maythen be separated from the body thereby depositing them in the tissuewall once the embedment device has embedded the tissue wall. Theprojections may be absorbable or configured to disintegrate over time,for example. In some embodiments, a positioning device may be used toassist in embedding or maintaining positioning of the body of theembedment device during embedment. The positioning device may beexpandable or biased outwardly to apply outward directed pressure andcompress the body against the tissue wall, configured to apply inwarddirected force, such as suction or negative pressure, to pull the tissuewall inward, or may temporarily cover or anchor the embedment device tohold the embedment device in place, e.g., using barbs, hooks or pins.The positioning device may be removed when the embedment device hasembedded the tissue wall.

In one embodiment, the body of the embedment device may be secured inposition along the interior side of the tissue wall with a positioningdevice. The embedment device may be configured to increase across-section dimension to apply outward directed force, for example.The method may include delivering the positioning device into the lumenand positioning the positioning device within the lumen, interior of thematerial or structure, to secure the body of the embedment device alongthe interior side of the tissue wall during the embedding. Thepositioning device may include one or more projections to penetrate thetissue wall but not puncture an exterior side of the tissue wall. In oneembodiment, the projections are attached to the body and comprise aprojection selected from a dissolvable or absorbable barbs, hooks, orpins.

In an embodiment, the method includes delivering a positioning deviceinto the lumen and positioning the positioning device within the lumen,interior of the material or structure, to secure the body of theembedment device along the interior side of the tissue wall during theembedding. The positioning device may include a body and one or moreprojections. The one or more projections may penetrate the tissue wallbut not puncture an exterior side of the tissue wall. In one example,the body of the positioning device is absorbable or dissolvable. In oneexample, the method includes removing the positioning device after theembedment device has embedded the tissue wall. In one embodiment, theprojections may be separated from the body thereby depositing theprojections in the tissue wall when the material or structure isembedded into the portion of the tissue wall. For example, theprojections may include an absorbable barb, hook, or pin. The body maythen be removed.

In one embodiment, the body of the embedment device, e.g., thereinforcement material or structure, may be heated or an electricalcurrent, continuous or pulse, may be conducted through it to assist inembedding the reinforcement material or structure into the portion ofthe tissue wall.

In some embodiments embedding the reinforcement material or structurecomprises threading a wire along the portion of the tissue wall. In thisor another embodiment embedding the reinforcement material or structurecomprises injecting a polymer into the portion of the tissue wall.

In another aspect, a method of anchoring an anchor device to a tissuewall of a biological lumen includes anchoring the anchor device to areinforced portion of the tissue wall wherein the reinforced portion ofthe tissue wall comprises a material or structure embedded in thereinforced portion of the tissue wall.

The anchor device may include a body having one or more outward facingprojections extending along a perimeter of the body. The projections maypenetrate, e.g., puncture, the portion of the tissue but do not puncturean exterior side of the tissue wall. The anchor device may applyoutwardly directed force along the portion of the reinforced portion ofthe tissue wall. The anchor device may anchor to the reinforced portionof the tissue wall via magnetic attraction wherein the material orstructure embedded in the reinforced portion of the tissue includesmagnets or magnet attractive materials.

The material or structure embedded in the reinforced portion of thetissue may include a portion that extends within the lumen. The anchordevice may include a body having one or more outward facing projectionsextending along a perimeter of the body. The projections maybepositioned to engage the portion of the material or structure thatextends within the lumen. In one example, the anchor device anchors tothe reinforced portion of the tissue wall via magnetic attraction, andthe portion of the material or structure that extends within the lumenincludes a magnet or magnet attractive material.

In still another aspect, an anchoring system for anchoring to a tissuewall of a biological lumen includes a medical device comprising agastric bypass sleeve; an anchor device positioned at a proximal end ofthe gastric bypass sleeve to anchor to a tissue wall in the esophagus;and a structure extending along the gastric bypass sleeve from theproximal end to a distal end to extend the gastric bypass sleeve fromthe esophagus, through the stomach, and position the distal end in thegastric bypass sleeve within the duodenum.

In some embodiments, the structure may be fixed in the gastric bypasssleeve. In one embodiment, the structure coils around the gastric bypasssleeve.

In various embodiments, the structure comprises a stiffening wire. Thestiffening wire may comprise a fixed wire embedded in the gastric bypasssleeve. In one embodiment, the stiffening wire may coil around thegastric bypass sleeve. The stiffening wire coils may be bendable todefine a path from the stomach into the duodenum.

In yet another aspect, an anchoring system for anchoring to a tissuewall of a biological lumen includes a medical device comprising agastric bypass sleeve; a first anchor device positioned at a proximalend of the gastric bypass sleeve to anchor to a tissue wall in theesophagus; and a second anchor device positioned at a distal end of thegastric bypass sleeve to anchor the distal end within the duodenum,wherein the second anchor device comprises a body configured to anchorwithin the duodenum. This may be by application of outwardly directedforce against the tissue wall or formation into a configuration thatdoes not permit retrograde passage into the stomach.

In various embodiments, the anchor system further includes an embedmentdevice to embed within a portion of the tissue wall of the esophagus inwhich the first anchor device anchors. The embedment device may includea structure selected from a mesh or coil having an embeddingconformation wherein the structure is biased to a cross-sectiondimension greater than a corresponding cross-section dimension ofesophagus to apply outwardly directed force along the portion of thetissue wall of the esophagus in which the first anchor device anchors.

In one embodiment, the first anchor system also includes a body havingprojections positioned along an outer perimeter to puncture the tissuealong the portion of the tissue wall of the esophagus in which the firstanchor device anchors. In this or another embodiment, the embedmentdevice comprises a polymer for injection or wire for threading along theportion of the tissue wall of the esophagus in which the first anchordevice anchors. The first anchor device may include a body havingprojections positioned along an outer perimeter to puncture the tissuealong the portion of the tissue wall of the esophagus in which the firstanchor device anchors.

In one embodiment, the anchor system also includes an embedment deviceto embed within a portion of the tissue wall of the duodenum in whichthe second anchor device anchors. The embedment device may include astructure selected from a mesh or coil having an embedding conformationwherein the structure is biased to a cross-section dimension greaterthan a corresponding cross-section dimension of duodenum to applyoutwardly directed force along the portion of the tissue wall of theduodenum in which the second anchor device anchors. The body of thesecond anchor device may include a doughnut or hollow cylinder shapedballoon. The embedment device may include a polymer for injection orwire for threading along the portion of the tissue wall of the duodenumin which the second anchor device anchors.

In still yet another aspect, a method of preventing dilation of abiological lumen includes embedding a material or structure into aportion of a tissue wall defining the lumen. The material or structuremay have a maximum cross-section dimension or perimeter corresponding toan allowable degree of dilation of the lumen.

In various embodiments, the material or structure comprises an embedmentdevice having a body. Embedding the material or structure may includedelivering the embedment device into the lumen and applying outwardlydirected force along an interior side of the tissue wall to embed thebody therein. In one embodiment, the body comprises a maximumcross-section dimension. The maximum cross-section dimension may be lessthan a corresponding cross-section dimension of the tissue wall andcorresponding lumen, taken from exterior sides of the tissue wall, suchthat the body does not migrate to an exterior side of the tissue wall.In one example, the body of the embedment device comprises a wire coilor a wire mesh.

In one embodiment, the body of the embedment device comprises anexpandable tube. The expandable tube may comprise a wire mesh or coil,for example.

In some embodiments, the body of the embedment device may have anembedding conformation and an embedded conformation. The body may applythe outwardly directed force in the embedding conformation anddiscontinue application of the outwardly directed force in the embeddedconformation. In the embedded conformation, a cross-section dimension ofthe body may be less than a corresponding cross-section dimension of thetissue wall and corresponding lumen, taken from exterior sides of thetissue wall, such that the body does not migrate to an exterior side ofthe tissue wall.

In various embodiments, applying the outwardly directed force along aninterior side of the tissue wall comprises compressing the material orstructure against the interior side of the tissue wall. Compressing thematerial or structure against the interior side of the tissue wall maycomprise positioning an inflatable device within the lumen and inflatingthe inflatable device such that the inflatable device obtains across-section sufficient to compress the reinforcement material orstructure against the interior side of the tissue wall.

In some embodiments, compressing the material or structure against theinterior side of the tissue wall comprises applying a suction ornegative pressure within the lumen.

In one embodiment, the body may be secured in position along theinterior side of the tissue wall with a positioning device. The methodmay include delivering the positioning device into the lumen andpositioning the positioning device within the lumen, interior of thematerial or structure, to secure the body of the embedment device alongthe interior side of the tissue wall during the embedding. Thepositioning device may include one or more projections to penetrate thetissue wall but not puncture an exterior side of the tissue wall. In oneembodiment, the projections are attached to the body and comprise aprojection selected from a dissolvable or absorbable barbs, hooks, orpins.

In an embodiment, the method includes delivering a positioning deviceinto the lumen and positioning the positioning device within the lumen,interior of the material or structure, to secure the body of theembedment device along the interior side of the tissue wall during theembedding. The positioning device may include a body and one or moreprojections. The one or more projections may penetrate the tissue wallbut not puncture an exterior side of the tissue wall. In one example,the body of the positioning device is absorbable or dissolvable. In oneexample, the method includes removing the positioning device after theembedment device has embedded the tissue wall. In one embodiment, theprojections may be separated from the body thereby depositing theprojections in the tissue wall when the material or structure isembedded into the portion of the tissue wall. For example, theprojections may include an absorbable barb, hook, or pin. The body maythen be removed.

In some embodiments, embedding the material or structure may be assistedby heating or conducting an electrical current through the material orstructure to assist in embedding the material or structure into theportion of the tissue wall. In one embodiment, embedding the materialmay be assisted by dimensions of the material or structure favorable forembedding, e.g., a leading edge or wedge, oriented toward the tissuewall. In some embodiments, embedding may be assisted by biological orchemical treatments. For example, the material or structure may includeor be coated or enveloped by an acid to disrupt the tissue lining thetissue wall.

In some embodiments, the body includes one or more outwardly directedprojections configured to penetrate, e.g., puncture, tissue. Theprojections may be dimensioned to not puncture an exterior side of thetissue wall.

In one embodiment, the material or structure comprises threading a wirealong the portion of the tissue wall. In this or another embodiment,embedding the material or structure comprises injecting a polymer intothe portion of the tissue wall.

In one aspect, a method of providing anchorage within a gastrointestinaltract lumen includes embedding a body of an embedment device within aportion of a tissue wall defining a gastrointestinal tract lumen. Theembedment device may include one or more structures that extend from thebody to position within the lumen when the body is embedded within thetissue wall. The one or more structures may include a coupling platformconfigured to couple to a corresponding coupling platform of an anchordevice in situ to anchor the anchor device within the lumen.

In one example, embedding the body includes applying outwardly directedforce along an interior side of the tissue wall to embed the bodytherein. Applying the outwardly directed force along an interior side ofthe tissue wall may include compressing the body against the interiorside of the tissue wall. The body of the embedment device may have across-section dimension greater than an initial correspondingcross-section dimension of the lumen to therein apply the outwardlydirected force along the interior side of the tissue wall to embedtherein. The cross-section dimension of the body may be less than acorresponding cross-section dimension of the tissue wall andcorresponding lumen, taken from exterior sides of the tissue wall, suchthat the body does not migrate to an exterior side of the tissue wall.

In an above or another example, the body may include a wire mesh. Thewire mesh may include one or more physical blocks extending over one ormore openings within the mesh to prevent migration of the body to anexterior side of the tissue wall. In various embodiments, the bodyincludes an arcuate perimeter, a wire wherein embedding the body mayinclude threading the wire through the tissue wall, or a polymer whereinembedding the body may include injecting the polymer into the tissuewall. In one example, the body of the embedment device includes atubular structure that is expandable or biased to obtain a cross-sectiondimension greater than an initial corresponding cross-section dimensionof the lumen to therein apply the outwardly directed force along theinterior side of the tissue wall to embed therein. The tubular structuremay include a wire mesh or coil. In some configurations, one or moredissolvable or absorbable barbs, hooks, or pins may extend from the bodyto assist in stabilizing the body prior to or during embedding.

In an above or another example, the coupling platform may include one ormore couplings configured to couple to corresponding couplings of thecorresponding coupling platform. The one or more couplings comprise amagnet, magnetic attractive material, hook, latch, clip, loop, rail,groove, adhesive, or combination thereof.

In an above or another example, the anchor device includes a medicaldevice and the method further includes coupling a medical device to thecoupling platform in situ. The method may further include decoupling theanchor device from the coupling platform in situ. The method may furtherinclude re-coupling the medical device to the coupling platform in situor coupling another medical device to the coupling platform in situ.

In still another aspect, a method of anchoring a medical device within agastrointestinal tract lumen includes delivering a medical device withina gastrointestinal tract lumen proximal to a coupling platform. Thecoupling platform may include one or more coupling structures positionedwithin the lumen configured to couple to one or more coupling structurespositioned on or extending from the medical device. The couplingplatform may be attached or coupled to a body of an embedment deviceembedded in a portion of a tissue wall defining the lumen. The methodmay further include coupling the one or more coupling structures of themedical device to the one or more coupling structures of the couplingplatform to anchor the medical device within the lumen.

In yet another aspect, an anchoring system for anchoring a medicaldevice within a gastrointestinal tract lumen may include a medicaldevice including a gastric bypass sleeve and an embedment devicepositioned at a proximal end of the gastric bypass sleeve. The embedmentdevice may include a body configured to embed a tissue wall defining agastrointestinal lumen. The body may include a wire mesh positionedalong an outer perimeter of the body that is biased outwardly toincrease a diameter of the outer perimeter of the body. In one example,the wire mesh has a tubular shape and extends continuously along theperimeter.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the described embodiments are set forth withparticularity in the appended claims. The described embodiments,however, both as to organization and manner of operation, may be bestunderstood by reference to the following description, taken inconjunction with the accompanying drawings in which:

FIG. 1 illustrates an embedment device according to various embodimentsdescribed herein;

FIG. 2 illustrates an embedment device according to various embodimentsdescribed herein;

FIG. 3 illustrates an embedment device according to various embodimentsdescribed herein;

FIG. 4 illustrates an embedment device according to various embodimentsdescribed herein;

FIG. 5 illustrates an embedment device according to various embodimentsdescribed herein;

FIG. 6 illustrates an embedment device according to various embodimentsdescribed herein;

FIG. 7 illustrates a cross-section of an embedment device according tovarious embodiments described herein;

FIG. 8 illustrates an embedment device according to various embodimentsdescribed herein;

FIG. 9 illustrates an anchor device according to various embodimentsdescribed herein;

FIG. 10 illustrates an anchor device according to various embodimentsdescribed herein;

FIG. 11 illustrates an anchor device according to various embodimentsdescribed herein;

FIG. 12 illustrates an anchor device according to various embodimentsdescribed herein;

FIG. 13 illustrates an anchor device according to various embodimentsdescribed herein;

FIG. 14 illustrates a cross-section of an anchor device according tovarious embodiments described herein;

FIG. 15 illustrates an anchor device including a medical deviceaccording to various embodiments described herein;

FIG. 16 illustrates an anchor device including a medical deviceaccording to various embodiments described herein;

FIG. 17 illustrates an anchor device including a medical deviceaccording to various embodiments described herein;

FIG. 18 illustrates an anchor device including a medical deviceaccording to various embodiments described herein;

FIG. 19 illustrates an anchor device including a medical deviceaccording to various embodiments described herein;

FIG. 20A illustrates an anchor device that includes a medical deviceaccording to various embodiments described herein;

FIG. 20B illustrates the anchor device of FIG. 20A anchored within abiological lumen according to various embodiments described herein;

FIG. 21A illustrates a device comprising two anchor devices and amedical device according to various embodiments described herein;

FIG. 21B illustrates the device of FIG. 21A anchored within a biologicallumen according to various embodiments described herein;

FIG. 22A illustrates an anchor device including a medical deviceaccording to various embodiments described herein;

FIG. 22B illustrates the anchor device and medical device of FIG. 22Aanchored within a biological lumen according to various embodimentsdescribed herein; and

FIG. 23 illustrates a method of implanting an embedment device accordingto various embodiments described herein.

FIGS. 24A-24D illustrate example cross-section shapes of wires accordingto various embodiments wherein FIG. 24A includes a round cross-sectionshape, FIGS. 24B & 24D include quadrilateral cross-sections shapes, andFIG. 24C includes a wedge cross-section shape;

FIG. 25 illustrates a cross-section of a tissue wall wherein apositioning device is assisting the positioning or embedment of anembedment device according to various embodiments;

FIGS. 26A-26D illustrates positioning devices for assisting in thepositioning or embedment of an embedment device according to variousembodiments;

FIG. 27 illustrates an embedment device according to variousembodiments;

FIG. 28 illustrates an embedment device according to variousembodiments;

FIG. 29 illustrates an embedment device according to variousembodiments;

FIG. 30 illustrates an embedment device according to variousembodiments;

FIG. 31 illustrates an embedment device according to variousembodiments;

FIGS. 32A & 32B illustrate an embedment device, wherein FIG. 32A is across-section view taken along line 32A of FIG. 32B, according tovarious embodiments;

FIG. 33 illustrates an embedment device including a coupling platformcomprising inwardly directed projections configured to extending intothe lumen when the body embeds according to various embodiments; and

FIG. 34 illustrates a medical device including an embedment deviceaccording to various embodiments.

DESCRIPTION

Anchoring systems and associated devices and methods of anchoringdevices within biological lumens which may include reinforcing a tissuewall defining a biological lumen are described herein.

The anchoring systems and associated devices and methods describedherein may be used to anchor devices. The devices anchored may includemedical devices or platforms for coupling to medical devices to beanchored within a biological lumen. The medical devices may includediagnostic, therapeutic, regulatory, sensors, separation, transport, orother devices. For example, anchor devices or devices that may becoupled to an anchored platform may include medical devices thatregulate or modify flow of material within the lumen, detect or analyzecomponents of material within the lumen, release of substances into thelumen such as medications or other therapeutic substances, or observe ormeasure conditions or state within the lumen.

In some embodiments, an anchoring system includes an embedment deviceconfigured to embed a tissue wall defining a biological lumen. Theembedment device may strengthen a tissue wall. For example, an embedmentdevice may include a structure that embeds the tissue wall and therebyreinforces the tissue wall. The embedment device may be configured tomaintain a dimension or range of dimension with respect to the lumen.For example, the embedment device may limit a cross-section dimensionsuch as a diameter or circumference of the lumen, which may includemaintaining an overall cross-section shape of the lumen. Thus, anembedment device may prevent a lumen from increasing or decreasingbeyond a cross-section dimension such as diameter or circumference,which may include deformation of a cross-section shape. In one example,an embedment device prevents a stomach from expanding after gastricreduction surgery. In another example, an embedment device preventsesophageal dilation in patients with Achalasia.

The anchoring system and/or the embedment device may provide anchoragefor various objects or structures, such as medical devices, within thegastrointestinal tract. While embedded, the embedment device may providea platform for anchoring of medical devices. The platform may be used tocouple medical devices in situ. In some embodiments, the embedmentdevice and/or medical device may be configured for decoupling in situ toallow removal, replacement, or interchanging of medical devices. Someconfigurations may utilize intermediate structures that couple betweenthe embedment device and a medical device. In one embodiment, anembedment device is integral with that of a medical device to provideanchorage within the gastrointestinal tract. When embedded, theembedment device may be configured to remain embedded for any period oftime, such as greater than about 1 month, greater than about 6 months,greater than about 1 year, greater than about 2 years, greater thanabout 4 years, or permanently. Thus, the anchoring system and/orembedment device may provide chronic anchorage within thegastrointestinal tract for extended fixation of medical devices.Providing such an anchoring platform within the gastrointestinal tractcapable of providing long-term fixation and stable retention of medicaldevices therein opens new doors for new and improved treatmenttechniques for chronic diseases and conditions such as diabetes,obesity, and ulcer diseases.

In various embodiments, an anchoring system includes a self-expandingembedment device to push into a tissue wall to embed therein. In someembodiments, the embedment device comprises a body having a generallytubular configuration. The embedment device may be configured to notembed too deep within the wall. For example, migration of the embedmentdevice through the tissue wall may be prevented by a maximum dimensionor perimeter defined by the device or a physical block. A positioningdevice may be used to accelerate the embedment process or assist inretaining the position of the embedment device until embedded. An anchordevice may anchor to the embedded device by penetrating tissue or byengaging a projection of the embedment device within the lumen.

In various embodiments, an anchoring system includes an anchor deviceconfigured to stably anchor within a biological lumen. An embedmentdevice may be used to reinforce and strengthen a tissue wall to assistin anchoring of the anchoring device. The anchor device may anchor alongor adjacent to one or more reinforced portions of a wall defining thebiological lumen. For example, an anchor device may anchor within alumen by application of outwardly directed force along a reinforcedportion of a tissue wall. The embedment device may prevent the tissuewall from expanding away from the outwardly directed force and therebyimprove grip from the outwardly directed force. In some embodiments, ananchor device may anchor within a lumen utilizing projections such ashooks that engage the embedded structure or penetrate, e.g., puncture,into reinforced tissue. As described in more detail below, otherarrangements for anchoring an anchoring device may be used, such asincorporating magnets.

In some embodiments, the anchoring system includes an anchor device thatcomprises a medical device. In these or other embodiments, the anchoringsystem includes an anchor device that comprises a platform to couple amedical device. Such a modular configuration may allow utilization ofthe anchor device as a platform for implanting and removing devices tobe anchored by the anchor device. Anchor devices that include orincorporate medical devices may similarly be configured to utilize theembedment device as a platform for implanting and removing the medicaldevice having the integrated anchoring device platform. In still furtherembodiments, the embedment device includes anchoring structuresconfigured to couple to an anchor device.

The anchor system is generally described herein with respect todimension control, reinforcement, anchoring, and combinations thereofwithin the gastrointestinal tract; however, the anchor system may finduse with respect to other lumens and tissue walls defining such lumens.For example, various embodiments of the anchor system, which may includeassociated devices and methods thereof, may be applied to controldimensions, reinforce, or anchor devices within tissue defining abiological lumen, which may include embedding a structure within atissue wall, selected from a lumen within the vascular system, artery,vein, gastrointestinal tract, esophagus, cardia, stomach, pylorus, smallor large intestines, duodenum, colon, rectum, urinary tract, bladder,prostate, urethra, reproductive system, vagina, uterus, fallopian tubes,respiratory system, larynx, or bronchi, for example.

With reference to FIGS. 1-8 , illustrating embedment devices 10according to various embodiments described herein, an anchor system 2may include an embedment device 10. The embedment device 10 may includea body 12. The body 12 may comprise a rigid structure, flexiblestructure, injected polymer, threaded wire, as examples, configured toreinforce or strengthen a biological lumen. In one embodiment, the bodymay be rigid with respect to expansion of a cross-section greater than amaximum cross-section to limit dilation of a lumen but may becollapsible or resiliently collapsible to allow contraction of a lumen.In some embodiments, the body 12 may comprise a generally tubularstructure. As introduced above, some embodiments of an embedment device10 are dimensioned to apply outwardly directed force along a tissuewall. The outwardly directed force may result in all or a portion of thebody 12 embedding in the tissue wall. The portion of the body thatembeds may be referred to as an embedded structure of the body.

In various embodiments, the body 12 may be biased to expand outwardly orto an increased diameter than that of the lumen into which itreinforces. In some embodiments, the force is due to a dimension of thelumen being less than a corresponding dimension of the body 12 resultingin the restricted dimension, such as diameter, of the lumen causingconformational stress along the corresponding dimension of the body 12.The conformational stress may result in application of outward forceonto the lumen wall. The body 12 may be biased to expand to apredetermined maximum embedded dimension. In some embodiments, the body12 obtains a dimension when implanted in the lumen, forcing the lumen toobtain the greater corresponding dimension of the body 12. The dimensionobtained by the body 12 may correspond to its maximum embeddeddimension. In either instance, the force applied by the body 12 drivesembedment of the body 12 into the lumen to reinforce the lumen. Invarious embodiments, the maximum embedded dimension of the body 12 maybe between approximately 0.5 mm and approximately 1 cm larger than thecorresponding diameter of the lumen when implanted. In one example, thediameter of the body 12 is between approximately 1 mm and approximately5 mm, such as between approximately 1 mm and approximately 3 mm, largerthan the corresponding diameter of the lumen. In some embodiments,outward directed force may be substantially evenly applied by the body12 along the lumen. In other embodiments, force may be differentiallyapplied. With further reference to FIG. 23 , delivering the embedmentdevice 10 to a target site 24 may include delivery utilizing endoscopyand fluoroscopy together with an endoscopic delivery device 20. Forexample, the delivery device 20 may include an endoscopic catheter. Inone application, the embedment device 10 may be delivered using a wireguided catheter. The embedment device 10, for instance, may be collapsedand inserted into a sheath 22. The catheter may be positioned underfluoroscopy to the target site 24 within the biological lumen 26. Aplunger 25 may be used to urge the embedment device 10 from the sheath22. The delivery device 20 or a similar delivery device may be used todeliver other devices, such as an anchor device.

To assist in delivery of the embedment device 10 to a target site 24within a biological lumen, various embodiments of the embedment device10 may comprise a delivery conformation wherein the body 12 is reducedin one or more dimensions for delivery. The delivery device 20 maycouple, e.g., attach, hold, or retain, the embedment device 10 fordelivery to the target site 24. In some embodiments, the anchor system 2includes a retainer 29 configured to retain the embedment device 10 inthe delivery conformation during delivery to the target site 24. Theretainer 29 may be a mechanical retention device such as one or moreclamps, latches, calipers, articulators, compressors, pockets or slots,such as those defining restrictive volumes configured to mechanicallyretain the embedment device 10 in the delivery conformation. In theexample delivery device 20 illustrated in FIG. 23 , the retainer 29comprises a restrictive volume along a distal portion of the sheath 22.In some embodiments, a retainer separate from a delivery device 20 maybe used in addition to or instead of a retainer 29 associated with adelivery device 20. For example, a retainer 29 may include one or morebrackets, tubes, braces, cuffs, or clamps configured to retain theembedment device 10 in the delivery configuration. The delivery device20 may release the embedment device 10 at the target site 24. Releasingthe embedment device 10 may also release the retainer 29. In someembodiments, the delivery device 20 or another delivery device isconfigured to remove the retainer 29. As described in more detail below,the embedment device 10 may include a shape change or shape memorymaterial. In some such embodiments, the embedment device 10 may not bemechanically retained in the delivery conformation during delivery. Thedelivery device 20 or another device may be used to encourage or driveexpansion of the embedment device 10 to the embedding conformation atthe target site 24 such that the expanded configuration of the embedmentdevice 10 applies outwardly directed force to the walls surrounding thelumen 26 to encourage embedment of the embedment device 10.

With continued reference to FIGS. 1-8 , as introduced above, the body 12may be configured to increase a cross-section dimension. For example,the body 12 may increase a cross-section of the body 12 from a firstcross-section dimension to a second cross-section dimension. The firstcross-section dimension may correspond to the cross-section of the body12 in the delivery conformation or the embedding conformation. Thesecond cross-section dimension may correspond to the cross-section ofthe body 12 in the embedding conformation or the embedded conformation.The body 12 may be delivered into a lumen. Therein the body 12 may beinitiated or biased to increase the cross-section. For example, the body12 in the delivery or embedding conformation may include the firstcross-section dimension and may be biased to obtain the secondcross-section dimension.

In various embodiments, the body 12 may increase or be biased toincrease the cross-section in the embedding conformation from the firstcross-section dimension, which may correspond to the deliveryconformation or an intermediate conformation, to the secondcross-section dimension. The second cross-section dimension may begreater than the corresponding cross-section dimension of the lumen suchthat the body 12 applies outward force onto the tissue wall of the lumeneither when the second cross-section is obtained or during thetransition to the second cross-section dimension. In one example, thesecond cross-section dimension corresponds to the embedded conformationand the body 12 may quickly embed the tissue wall in the embeddingconformation. It will be appreciated that the embedding conformation maybe a transitional conformation wherein the cross-section is increasingor may correspond to the embedded conformation wherein the body 12 hasobtained a cross-section greater than the corresponding lumen to thereinembed. For example, the embedding conformation may include the body 12transitioning the cross-section from the first cross-section dimensionto the second cross-section dimension. In one embodiment, the secondcross-section dimension is the maximum cross-section dimension the body12 is configured to expand. In one example, the body 12 may embed thetissue wall prior to obtaining the second cross-section dimension andthe embedded conformation comprises a cross-section dimensionintermediate of the first and second cross-section dimensions.

With specific reference to FIG. 1 an example embedment device 2 mayinclude a body 12 comprising a mesh structure, such as a wire mesh orweave of a plurality of intersecting or overlaid wires 30 definingopenings 32 therebetween. The mesh structure may be dimensioned tocontact and exert force, energy, a chemical or biologic interaction withone or more portions of tissue defining a biological lumen and thereinembed to reinforce the wall. In some examples, the wires 30 forming themesh may have a diameter of between approximately 0.001 andapproximately 1 mm, such as approximately 0.01 mm. In some embodiments,larger or smaller diameter wire 30 may be used. In various embodiments,the wires 30 may be arranged to form linear or rounded sides that definethe openings 32. For example, wires 30 may be arranged to defineopenings 32 having geometric or non-geometric shapes, such as circles,ovals, triangles, trapezoids, diamonds, squares, rectangles, hexagons,or other multi-sided shapes or free form, which may include multipleshapes, sides, sizes, of openings 32 along the body 12. The openings 32defined by the wires 30 mesh may have a largest dimension greater thanthe diameter of wire 30 defining the opening. In the illustratedexample, the wires 30 define openings 32 having a general diamond shape.

The body 12 may have any suitable shape. In various embodiments, thebody 12 includes a perimeter positioned to embed a tissue wall. In oneexample, the body 12 includes two or more structures that are biasedaway from each other. In a further example, the body 12 may include anoutwardly positioned structure or wall that extends along a perimeter ofthe body 12 and an inner opening or lumen. The opening may be defined bythe outwardly positioned structure or wall or may be defined by otherstructures positioned inwardly of the outwardly positioned structure orwall. In one embodiment, the body 12 comprises an arcuate or ring shapedperimeter. The perimeter may be continuous or discontinuous. In variousembodiments, the body 12 comprises a tubular structure. In someexamples, the body 12 may have a cross-sectional shape corresponding toa cross-sectional shape of the lumen for which it is to reinforce. Insome embodiments, the body 12 may be similar to a wire mesh stent havinga general arcuate shape, such as a cylindrical or tubular shape, andthat defines a generally arcuate opening. In some examples, the body 12may have a cross-sectional shape having a diameter greater than adiameter of the lumen it embeds at one or more cross-section locations.For example, the diameter of the body 12 may be between approximately0.5 mm and approximately 1 cm larger than the corresponding diameter ofthe lumen. In one example, the diameter of the body 12 is betweenapproximately 1 mm and approximately 5 mm larger than the correspondingdiameter of the lumen. While a single mesh layer is illustrated in FIG.1 , in some embodiments, an embedment device may comprise a body havingmultiple layers for embedding within a tissue wall.

In various embodiments, the body 12 may be between about 20 to about 45mm in diameter. In these or another embodiment, the body 12 may bebetween about 30 and about 55 mm in length or more. Such dimensions mayfind use in gastrointestinal tract applications, for example. In someembodiments wherein the embedment device 10 is intended for vascularapplications or other applications, the body 12 may have a diameter lessthan 30 mm, such as less than 5 mm. The length of the body 12 may alsobe less than 40 mm. Some embodiments may include a body 12 having adiameter less than 30 mm and a length less than 40 mm or greater than 55mm. Other embodiments may include a body 12 having a diameter less than30 mm and a length greater than 40 mm or greater than 50 mm. Still yetother embodiments may include a body 12 having a diameter greater than45 mm and a length less than 40 mm or greater than 55 mm.

The wires 30 may comprise metal, alloy, or polymer wire sufficientlyrigid to apply outwardly directed force at one or more locations along atissue wall of a lumen when in an embedding conformation. The forceapplied to the wall may encourage embedment of the body 12 within thewall. As noted above and elsewhere herein, in some embodiments, the body12 includes an expandable mesh or a spiral waveform.

In some embodiments, the dimensional extent the outwardly directed forceis provided may be limited. For example, the body 12 may be configuredto provide outwardly directed force in the embedding conformation untilthe body 12 has obtained a predetermined size dimension or embeddedconformation. For instance, the body 12 may be configured to apply anoutwardly directed force in an embedment conformation until a dimensionof the body 12 has expanded to a predetermined size, which may begreater than a corresponding dimension of the lumen. The predeterminedsize may correspond to an embedded conformation. For example, thediameter of the body 12 in the embedded conformation may be betweenapproximately 0.5 mm and approximately 1 cm larger than thecorresponding diameter of the lumen. In one example, the diameter of thebody 12 in the embedded conformation is between approximately 1 mm andapproximately 5 mm larger than the corresponding diameter of the lumen.

The embedment device may comprise various lengths of embeddingstructures configured to embed a longitudinal length of a tissue wall.For instance, example embedding lengths may be approximately 0.25 cm orgreater, such as approximately 0.5 cm or greater, approximately 1 cm orgreater, approximately 2 cm or greater, approximately 3 cm or greater,approximately 4 cm or greater, approximately 5 cm or greater,approximately 6 cm or greater, approximately 7 cm or greater,approximately 8 cm or greater, approximately 9 cm or greater, orapproximately 10 cm or greater. Additionally, and as noted elsewhereherein, embedment structures may circumferentially embed along all or aportion of a circumference of a tissue wall. For example, embeddingstructures may be configured to embed between 100% and approximately 5%of the circumference of a tissue wall, such as approximately 10% orgreater, approximately 20% or greater, approximately 30% or greater,approximately 40% or greater, approximately 50% or greater,approximately 60% or greater, approximately 70% or greater,approximately 80% or greater, or approximately 90% or greater.

The body 12 may comprise a material or configuration that may becompressed or otherwise reduced, e.g., deformed, in one or moredimensions in a delivery conformation for delivery to a target site,see, e.g., FIG. 23 . Wires 30 may comprise a polymer, metal, or alloy,such as stainless steel, that may be delivered to a target site in alumen in a resiliently compressed configuration. For example, the body12 may be extended in length, which may reorient wires 30 to reduce adiameter or width dimension of the body 12 for delivery. The compresseddelivery conformation may be applied by a delivery device that retainsthe body 12 in the compressed configuration either directly orindirectly, see, e.g., FIG. 23 . The body 12 may be compressed indiameter or deformed for delivery to the target site as explained aboveand elsewhere herein. For example, a delivery device may include a tubeor cannula that retains the body 12 in a delivery conformation havingone or more reduced dimensions. At the target site, the delivery devicemay remove the retention to allow the body 12 to resiliently expand orreorient toward and against the tissue wall in the embeddingconformation and thereon apply outwardly directed force.

In some embodiments, wires 30 comprise nitinol or other shape memory orshape change material configured to be delivered to the target site in adelivery conformation comprising a relaxed configuration, strainedconfiguration, deformed configuration, compressed configuration oranother configuration wherein the body 12 comprises one or more reduceddimensions. At the target site the body 12 may transition to theembedding conformation. The transition may result upon removal of adeforming force or due to an environmental condition at the target siteor upon introduction of a shape change queue or condition introducedwithin the lumen or externally directed to the lumen. For example,chemical, heat, pH, magnetic, electric, or electromagnetic field queues,may be employed to initiate a conformational change. The conformationalchange may result in the body 12 applying outwardly directed force alongone or more locations of the tissue wall defining the lumen. The body 12may subsequently embed within the wall.

In some embodiments, the embedment device 10 may comprise otherstructures. For example, the embedment device 10 may comprise one ormore rings. The rings may be separate or connected, such as in a coilconfiguration or a plurality of rings separated by one or moreconnecting members, such as wires, along one or more positions along thecircumference of the rings.

FIG. 2 illustrates an embedment device 10 comprising a body 12. The body12 comprises a generally tubular structure having a helicalconfiguration to various embodiments described herein. The body 12comprises a plurality of annular rings 36 arranged in a helicalconfiguration. For example, the body 12 may comprise coiled wire 38 inan embedding and/or embedded conformation.

The helical structure of the body 12 may be formed from materials asdescribed above and elsewhere herein, e.g., materials described withrespect to the mesh structure of the body 12 of the embedment deviceshown in FIG. 1 . For example, the coiled wire 38 may comprise metal,alloy, or polymer wire sufficiently rigid to apply outwardly directedforce at one or more locations along a tissue wall of a lumen when in anembedding conformation. The force applied to the wall may encourageembedment of the body 12 within the wall. In some embodiments, thedimensional extent the outwardly directed force is provided may belimited. For example, the body 12 may be configured to provide outwardlydirected force in the embedding conformation until the body 12 hasobtained a predetermined size dimension or embedded conformation. Forinstance, the body 12 may be configured to apply an outwardly directedforce in an embedment conformation until a dimension of the body 12 hasexpanded to a predetermined size, which may be greater than acorresponding dimension of the lumen. The predetermined size maycorrespond to an embedded conformation.

The body 12 may comprise a material or configuration that may becompressed or otherwise reduced in one or more dimensions in a deliveryconformation for delivery to a target site, see, e.g., FIG. 23 . Thecoiled wires 30 may comprise a polymer, metal, or alloy, such asstainless steel, that may be delivered to a target site in a lumen in aresiliently compressed configuration. For example, the body 12 may beextended or reduced in length, which may reorient rings 36 to reduce adiameter, width, or thickness dimension of the body 12 for delivery. Inone embodiment, the embedment device 10 may be delivered with the coiledwire 38 rings 36 resiliently compressed wherein the rings 36 arereoriented at the target site to extend along the lumen and thereinapply outwardly directed force to the wall. In one embodiment, thecoiled wire 38 may be resiliently extended in length, thereby reducingthe diameter of the rings 36 for delivery to the target location. Oncepositioned at the target location, the coiled wire 38 may be released bythe delivery device. As noted above, the delivery device maymechanically retain the coiled wire 38 in a compressed, extended,deformed, or other configuration either directly or indirectly whereinthe body 12 or rings 36 thereof are reduced in one or more dimension.For example, a delivery device may include a tube or cannula thatretains the body 12 in a delivery conformation having one or morereduced dimensions, which may be similar to the delivery devicedescribed with respect to FIG. 23 . In one example, the delivery devicemay include a retainer comprising a clamp that physically restrains thecoiled wire 38 from reobtaining one or more dimensions in which the body12 has been reduced in the delivery conformation. At the target site,the delivery device may remove the retention to allow the coiled wire 38to resiliently expand or reorient toward and against the tissue wall andthereon apply outwardly directed force in an embedding conformation. Asdescribed above with respect to FIG. 1 , the body 12 may be betweenapproximately 0.5 mm and approximately 1 cm larger than thecorresponding diameter of the lumen. In one example, the diameter of thebody 12 is between approximately 1 mm and approximately 5 mm, such asbetween approximately 1 mm and approximately 3 mm, larger than thecorresponding diameter of the lumen. The body 12 may similarly be biasedto a diameter greater than the lumen. For example, the body 12 may bebiased in an embedding confirmation to an embedded conformation betweenapproximately 0.5 mm and approximately 1 cm larger than thecorresponding diameter of the lumen, such as between approximately 1 mmand approximately 5 mm or between approximately 1 mm and approximately 3mm.

In some embodiments, the coiled wire 38 comprises nitinol or other shapememory or shape change material configured to be delivered to the targetsite in a delivery conformation comprising a relaxed configuration,strained configuration, deformed configuration, compressed configurationor another configuration wherein the body 12 comprises one or morereduced dimensions. At the target site the body 12 may transition to theembedding conformation. The transition may result upon removal of adeforming force or due to an environmental condition at the target siteor upon introduction of a shape change queue or condition introducedwithin the lumen or externally directed to the lumen. For example,chemical, heat, pH, magnetic, electric, or electromagnetic field queues,may be employed to initiate a conformational change. The conformationalchange may result in the body 12 applying outwardly directed force alongone or more locations of the tissue wall defining the lumen. The body 12may subsequently embed within the wall.

FIG. 3 illustrates an embodiment of an embedment device 10 wherein thebody 12 has a generally tubular structure comprising expandable tubing42. The expandable tubing 42 includes a mesh similar to FIG. 1 andincludes wires 30 defining openings 32. The expandable tubing 42 isillustrated in an embedding conformation. In the embedding conformation,the expandable tubing 42 may be biased to expand outward, as indicatedby arrows A, B, C, and D. In some examples, the expandable tubing may bebiased outwardly differentially in one or more directions such thatperipheral regions corresponding to one or more diameters apply greaterforce and/or apply force to a greater extent than peripheral regionscorresponding to other diameters. In some examples, substantiallyequivalent outward directed force is applied about the perimeter in theembedding conformation. In some embodiments, the outward force mayresult in the lumen initially obtaining the cross-section of theexpandable tubing 42. The expandable tubing 42 may embed the lumen wall.The expandable tubing 42 may embed the wall and include a maximumdimension, which may correspond to the embedded conformation, which insome examples may also correspond to the dimensions of the embeddingconformation.

As introduced above, in some embodiments the body 12 may be betweenapproximately 0.5 mm and approximately 1 cm larger than thecorresponding diameter of the lumen. In one example, the diameter of thebody 12 is between approximately 1 mm and approximately 5 mm larger thanthe corresponding diameter of the lumen. The body 12 may similarly bebiased to a diameter greater than the lumen. For example, the body 12may be biased in an embedding confirmation to an embedded conformationbetween approximately 0.5 mm and approximately 1 cm larger than thecorresponding diameter of the lumen, such as between approximately 1 mmand approximately 5 mm.

An embedded system for attaching and holding an anchoring device in abiological lumen, such as the GI tract, may include an embedment device10 having a body 12. The anchor device, for example, may hook onto anembedded structure of the body 12 as described herein. In someembodiments, the embedded structure may be an injected material orthreaded wire. The anchoring device may hook into tissue a limiteddistance and engage the embedded structure. In another example, theanchoring device may engage a projection of the embedded structure thatprojects into the lumen. For instance, the body 12 may only partiallyembed a tissue wall such that a portion of the body 12 projects into thelumen. The projection structures may provide anchor points onto whichthe anchor device may engage to anchor within the lumen. As described inmore detail elsewhere herein, the engagement may include hooks ormagnets or other engagement or mating structures for coupling oradhesives, for example.

The embedded device 10 may reinforce the tissue wall limiting dilation,longitudinal movement, or both, of an anchoring device, which mayinclude a medical device or may further anchor to a medical device.

The embedment device 10 may apply outward directed force to embed intothe tissue wall defining the lumen or may be compressed against thetissue wall. In some embodiments, the embedment device 10 comprises aself-expanding body 12. The self-expanding body may have an expandingcross-section as described herein with respect to the examples andembodiments.

A method of embedding a structure or material into the wall of a GItract to strengthen the wall, prevent dilation, and/or anchor otherdevices in a manner that may resist forces, such as outward,linear/longitudinal, or both may include embedding an embedment device10 as described herein.

In various embodiments, the embedment device 10 may comprise a body 12having additional or other configurations. As introduced above, theembedment device 10 may include a body 12 having an expandable dimensionto transition from a delivery conformation to an embedding conformation,to apply force against a tissue wall in an embedding conformation, orboth. The dimension may be expanded upon release of a retaining orcompressing force or upon application of a conformational change queue,as described above. In further embodiments, the body 12 may be expandedutilizing a positioning device configured to expand a dimension of thebody 12. In one example, the body 12 may be lined with or associablewith a positioning device comprising a shape change or shape memorymaterial configured to increase a dimension of the body 12 in the lumen.In some embodiments, a body 12 comprising an expandable dimensionincludes a wire coil, elastic wire, rolled wire sheet, e.g., mesh sheet,structures attached by elastic or loose wire, which may include thread.

In some embodiments, a positioning device may be configured to secure aposition of the embedment device 10 during embedment of the embedmentdevice 10. The positioning device may include projections such as hooks,barbs, pins, or other anchors for engaging tissue. The projections maybe dissolvable or absorbable to disintegrate after the embedment device10 has embedded the tissue wall. The projections may be attached to theembedment device 10 in some embodiments. In another embodiment, thepositioning device comprises a body and one or more projections. Thebody may include structures to secure the position of the embedmentdevice 10 during embedment. For example, the body may include agenerally tubular structure such as a mesh. The body may include wiresor surfaces for positioning interior of the embedment device within thelumen to hold the embedment device in place. In some embodiments, apositioning device may further include projections such as hooks, barbs,pins, or other tissue engaging anchors as noted above and elsewhereherein. The projections may be dissolvable or absorbable to disintegrateafter the embedment device has embedded the tissue wall. In someembodiments, the body may also be dissolvable or absorbable. In oneembodiment, the body is configured to be removed following embedment ofthe embedment device.

In some embodiments, an outwardly directed force may be applied by apositioning device to compress the body 12 against a tissue wall toembed the body 12, which may include a structure or other reinforcementmaterial. For example, a positioning device may include an inflatabledevice, such as a balloon, that may be inflated within the lumen toapply outwardly directed force and thereby compress the body 12 againstthe tissue wall to embed the body 12 within. In another example, thepositioning device may include a pneumatic gas or other fluid filleddevice. In one example, the positioning device may include a devicehaving an actuator configured to actuate using pneumatic gas or fluid toapply outward directed force. In certain examples, the body 12 includesan embedment structure along a perimeter having a radial dimension withrespect to the body that is dimensioned to extend within multiple layersof a tissue wall. The embedment structure may completely embed withinthe tissue wall. For example, the body 12 may include a wire positionedalong a perimeter having a radial dimension that extends into the tissuewhen compressed there against wherein the wire embeds completely suchthat the tissue along the tissue wall surrounds the wire. In someexamples, the radial dimension may be greater than used with anoutwardly biased body 12 to extend a greater distance therein.

In some embodiments, an embedment device 10 may include a plurality ofembedment structures that may be embedded by application of outwardlydirected force wherein the structures are not connected. For example, aninflatable balloon or other pneumatic or fluid inflatable or actuatabledevice may temporarily retain a body comprising embedment structuresthat may be compressed against a tissue wall and then be released whensufficiently embedded. The release may be via release of magneticattraction, breaking of chemical or adhesive bonds, mechanical, ordeformation of the embedment structure or retaining structure, forexample. In one embodiment, an embedment device 10 includes a body 12comprising a wire mesh. The wire mesh may be temporarily retained, e.g.,positioned around a perimeter of an inflatable balloon. The balloon maybe positioned at a target site and inflated to expand the expandabledimension of the mesh and compress the body against a surrounding tissuewall. When the body embeds the wall, the balloon may be deflated andremoved.

In one embodiment, the body 12 of an embedment device 10 includescontact points positioned inwardly with respect to outwardly positionedembedment structures, to engage a positioning device comprising anexpansion device. The outwardly directed force applied by the expansiondevice at the contact points may translate to outwardly directed forcealong the embedment structures to more fully embed the embedmentstructures, such as completely. The contact points may includeconnectors that connect the embedment structures to the contact points.In various embodiments, contact points may partly or completely embedthe tissue wall.

In another embodiment, a positioning device includes expanders,ratchets, rails and groove, clamps, or other adjustable couplings. Forexample, pawl and teeth or gear track may be manipulated to introduce anexpanding force. In one example, a clamp may be used to couple portionsof the one or more annular structures. The clamp may include a gear,such as a worm gear, that may be manipulated to cause relative slidingbetween two coupled portions wherein at least one of the portionsincludes a gear track configured to operably interact with the gear toadjust a diameter or circumference of the positioning device and hencethe body 12. The adjustment may be manual, e.g., by manually turning thegear. In some embodiments, the adjustment may be accomplished in situremotely, external to the lumen, using magnets or electromagneticfields. In one embodiment, the positioning device includes a motoroperatively coupled to a gear and that may be remotely addressable toadjust the circumference or diameter of the positioning device. Forexample, the positioning device may include a receiver operativelycoupled to the motor to receive adjustment signals, such as magnetic orelectromagnetic communication signals. The positioning device may alsoinclude a controller to control the adjustment operation of thepositioning device. In some embodiments, the embedment device 10 isconfigured to include a positing device. For example, the embedmentdevice 10 may include expanders, ratchets, rails and groove, clamps, orother adjustable couplings. In one example, the embedment device 10 mayinclude projections to engage tissue as described above and elsewhereherein with respect to the positioning device. The projections may bedissolvable or absorbable.

Walls of the gastrointestinal track comprise various tissue layers suchas mucosa, submucosa, muscularis. The exterior epithelium of the mucosalayer is notably soft and turnovers quickly. The embedment devicepreferably embeds beyond the epithelium of the mucosa layer to embedwithin the mucosa, submucosa, or muscularis. In various embodiments,embedment may be accomplished approximately at the same time theembedment device is delivered to the target region. For example, ananchor device may be anchored to the embedment device within minutes orduring the same procedure. In some applications, suitable embedment foranchoring an anchor device may occur in 48 hours or less, 36 hours orless, 24 hours or less, or 12 hours or less. A method of strengthening aportion of a GI tract may include a method of accelerating the embedmentprocess. For example, a positioning device such as an inflatable balloonor cylinder, a rigid structure, sutures, hooks, or pins may be used tocompress the embedment device and/or retain the location of theembedment device. In one embodiment, a positioning device may include aplurality of staples or sutures that staple or suture the embedmentdevice into position but do not extend to an exterior side of the tissuewall. The embedment device may include various features configured toassist in embedment and retention. Such features may be configured todecrease the time to sufficiently embed for strengthening or anchoringof an anchor device, for example. Such features may be instead of or inaddition to outward directed force, compression, or negative pressureused alone or together with other devices such as positioning devices.

As introduced above (see, e.g., FIGS. 1-3 ), an embedment device 10 body12 may include wires 30. The wires may 30 have arcuate, multi-sided,geometric or non-geometric, such as square or rectangular cross-sectionshapes. FIGS. 24A-24D illustrate example cross-section shapes of wires30 a-30 d. The wire 30 a shown in FIG. 24A includes a circular or roundcross-section shape. The wires 30 b, 30 d shown in FIGS. 24B & 24Dinclude quadrilateral cross-sections shapes comprising square andrectangular cross-section shapes, respectively. The wire 30 c shown inFIG. 24C includes a wedge or triangular cross-section shape. In variousembodiments, an embedment device 10 body 12 (see, e.g., FIGS. 1-3 ) mayinclude wire 30 having a cross-section shape including an edge that isdirected outward of the body 12 to assist in penetration of the tissuewall. For example, wire 30 c may be orientated such that an edge 31 isdirected outward to engage tissue. In some embodiments, projections suchas hooks, barbs, or pins may be positioned on one or more sides of awire 30 a-30 d to hold or retain the position of the wire when embeddingin the tissue wall. As indicated above and elsewhere herein, suchprojections may be referred to as positioning devices.

As also introduced above, the embedment device 10 may have a body 12including an embedment structure configured to assist in the embeddingprocess. For example, wires 30 may be dimensioned to assist in tissuepenetration such that edges are directed toward tissue. In someembodiments, embedment structures, such as wires 30, may be coated withchemicals to disrupt tissue. For example, embedment structures may becoated with acid. In one embodiment, embedment structures may be heatedto assist in penetration of tissue. An electric current or electricpulse may be provided along the embedment structure to heat thestructure, provide cautery effect, or otherwise assist in penetratingtissue to embed the embedment structure therein.

FIG. 4 illustrates an embodiment of an embedment device wherein the body12 comprises threaded wire 48. The wire 48 may be threaded into a tissuewall 50 defining a lumen 52. The wire may include a metal, alloy, orpolymer wire that may be threaded along a perimeter of a wall defining alumen. The wire 48 may be threaded to define a generally tubular shapedefining a cross-section. According to various embodiments, a method ofreinforcing a biological lumen comprises threading a wire 48 along atissue wall defining the lumen. The wire 48 may be threaded into thetissue wall utilizing endoscopic techniques. Once threaded, the wire 48may embed the tissue wall 50.

FIG. 5 illustrates an embodiment of an embedment device 10 wherein thebody 12 comprises a polymer composition 54. The polymer composition 54may be embedded at one or more locations along a tissue wall 50 defininga biological lumen 52. The polymer composition 54 may be injected from asyringe or implanted. The polymer composition 54 may be injected as aliquid or semi-solid. In some examples, the polymer composition 54 maysolidify once injected or implanted and therein form an embeddedsemi-solid or solid. The polymer composition 54 may be embedded atmultiple locations along the tissue wall 50. In some instances, themultiple locations or pockets of polymer composition 54 mayinterconnect. The interconnection may be formed by connecting segmentsof polymer composition 54. In this or another embodiment,interconnections may be formed by threaded wires, such as threaded wires48 described with respect to FIG. 4 , which may be threaded or implantedbetween embedded pockets of embedded polymer composition 54. Forexample, the polymer may be a two part biocompatible polymer. In oneembodiment, the embedment device 10 includes a two part biocompatiblepolymer for injection into the mucosa or submucosa of a tissue walldefining the gastrointestinal tract.

With continued reference to FIGS. 1-8 , the embedment device 10 mayembed by pushing into the tissue. The embedment may effectively beinstantaneous or immediate. The embedment structure of the body 12 maypenetrate into the tissue wall.

Embedment of an embedment device 10 may be assisted by holding in placetemporarily with projections such as hooks, barbs, or pins. Theseprojections may be referred to as positioning devices or attachmentstructures (see, e.g., FIG. 6 ). In some embodiments, an anchor devicemay be immediately implanted at this time. The hooks or pins may beassociated with the embedment device or a separate device, such as apositioning device. For example, a portion of the embedment device 10 ora positioning device may temporarily assist in holding a position of theembedment device and may later be removed when sufficient embedment ofthe embedment device 10 has be achieved. The embedment device 10 may besutured into the wall.

In some embodiments, another device such as a positioning device mayassist in embedding or retaining the position of an embedment device bycompressing the embedment device 10 or embedment structure thereofagainst the tissue wall. For example, compression may be application ofoutward directed force, e.g., an inflatable device that may be inflatedwithin the lumen to compress the embedment device against the tissuewall.

FIG. 25 illustrates a cross-section of a tissue wall 50 defining a lumen52 wherein a positioning device 31 assists the positioning or embedmentof an embedment device 10 according to various embodiments. Theembedment device 10 includes a body 12 defining openings 32. In theillustrated embodiment, the openings 32 are formed by wires 30 or a wiremesh, which may be braided. The wires 30 are positioned against an innerlining 51 of the tissue wall 50.

The positioning device 31 includes a body 33 comprising a plurality ofprojections 35 extending from outer perimeter 37 of the body 33. Theprojections 35 may comprise hooks, barbs, or pins, for example. Theouter perimeter 37 of the body 33 may include an outer wall or structuresuch as a wire mesh, cross hatch, matrix, or rails, for example. Theouter perimeter 37 may include or expand to a complementarycross-section shape with respect to the body 12 or portion thereof. Thebody 33 may have a generally tubular cross-section, for example. Theprojections 35 extend through openings 32 to penetrate the inner lining51 of the tissue wall 51. In some embodiments, projections 35 include“U” shaped projections, such as staples or staple-like projections,wherein a pair of connected projection 35 penetrate the inner lining 51and straddle a portion or the embedment device 10 body 12, such as awire 30. In one embodiment, such projections may be uses without thebody 33 to secure the position of the embedment device 10 duringembedment. The positioning device 31 may be positioned with theembedment device 10 or separately. For example, the positioning device31 may be coupled to the embedment device 10 for delivery and may bedeployed with the embedment device 10. Both or one of the embedmentdevice 10 and positioning device 31 may be configured to expand orotherwise bias outward. The expansion or bias may result in theprojections 35 of the positioning device 31 penetrating the tissue wall50. In one example, the body 33 of the positioning device 31 comprisesan expandable material or an expandable cross-section shape as describedherein with respect to the embedment device 10. The body 33 may thenassist in embedding the embedment device 10, e.g., by applying outwarddirected force to compress the embedment device 31 against the innerlining 51 or preventing the embedment device from disengaging the innerlining 51 of the tissue wall 50. The positioning device 31 may beremoved when the embedment device 10 has sufficiently embedded thetissue wall 50.

Compression via a positioning device 31 may also be by application ofinward directed force or pulling of the inner lining 51 of the tissuewall 50 inward. For example, a suction or negative pressure may beapplied locally to open regions between embedment structures to pulltissue positioned in the openings inward.

With further reference to FIGS. 26A-26D, suction or negative pressuremay be applied by a positioning device 31. The body 33 of thepositioning device 31 may define various openings 39 from which suctionor negative pressure may be applied. The positioning device 31 maycomprise a tip for a surgical suction or aspirator. For example, thepositioning device 31 may couple to a surgical suction or aspiratornozzle.

The positioning device 31 may also be a device that may be positioningin the lumen and initiated to apply suction or negative pressure. Forexample, the body 33 may define an inner volume that fluidically coupleswith openings 39. The body 33 may be positioned in the lumen 52 and asuction may be applied, e.g., by actuating a plunger fluidically coupledto the interior volume or application of suction at a suctionopening/hole or valve, which may be a one way value or a valve that maybe modified to prevent fluid flow in one or more both directions. Oncesuction or negative pressure has been applied at the openings to tissue,the inner volume may otherwise be sealed or capped, which may beperformed by operation of a one-way valve.

The positioning device 31 illustrated in FIG. 26A includes a generallytubular body 31 defining a plurality of openings 39. The openings 39 maybe positioned to correspond to opening 32 locations defined by anembedment device 10 (see, e.g., FIG. 1 ). The positioning device 31 maybe configured for use as surgical suction tip. In another application,the positioning device 31 may be configured for use as a separate devicefor temporarily leaving in the lumen. For example, the body 33 mayinclude a distal wall 43 that encloses an inner volume 41 at a distalend of the body 33. Suction or negative pressure may be appliedproximally within the lumen to pull tissue into openings 39. Suction ornegative pressure may be applied by surgical suction, actuation of aplunger (not shown) within the inner volume 41, for example. The body 31may be sufficiently rigid to avoid collapsing upon application ofsuction or negative pressure. In some embodiments, a proximal end of thebody 31 may be capped or sealed to maintain the interior pressure. Forexample, the embodiment illustrated in FIG. 26D is similar to FIG. 26Aand includes a valve 47 at the proximal end enclosing the inner volume41 at the proximal end of the body 33. The valve may be a one way valveor a two way valve. For example, the valve 47 is a two way valve thatmay be initiated to maintain or release a vacuum pressure. In anotherexample, the valve 47 is a one way valve from which vacuum pressure maybe established. In one embodiment, the valve includes a plunger than maybe actuated in a first direction to create vacuum pressure and actuatedin a second direction to increase pressure. The body 33 may also includea vacuum release valve (not shown), e.g., along the proximal end wall.

The positioning device illustrated in FIG. 26B includes a generallytubular body 31 defining a plurality of openings 39. The openings 39 maybe positioned to correspond to opening 32 locations defined by anembedment device 10 (see, e.g., FIG. 2 ). The positioning device 31 maybe configured for use as surgical suction tip. In another application,the positioning device 31 may be configured for use as a separate devicefor temporarily leaving in the lumen. For example, the body 33 mayinclude a distal wall 43 that encloses an inner volume 41 at a distalend of the body 33. Suction or negative pressure may be appliedproximally within the lumen to pull tissue into openings 39. Suction ornegative pressure may be applied by surgical suction, actuation of aplunger (not shown) within the inner volume 41, for example. The body 31may be sufficiently rigid to avoid collapsing upon application ofsuction or negative pressure. In some embodiments, a proximal end of thebody 31 may be capped or sealed to maintain the interior pressure, forexample, as described above with respect to FIG. 26D. A valve, plunger,or both may also be included.

The positioning device illustrated in FIG. 26C includes a generallytubular body 31 defining a plurality of openings 39 along an outerperimeter. The openings 39 may be positioned to correspond to opening 32locations defined by an embedment device 10 (see, e.g., FIG. 1 ). Thebody 31 also includes an inner wall 45 defining a portion of the innervolume 41. The positioning device 31 may be configured for use assurgical suction tip. In another application, the positioning device 31may be configured for use as a separate device for temporarily leavingin the lumen. For example, the body 33 may include a distal wall 43 thatencloses an inner volume 41 at a distal end of the body 33. Suction ornegative pressure may be applied proximally within the lumen to pulltissue into openings 39. Suction or negative pressure may be applied bysurgical suction, actuation of a plunger (not shown) within the innervolume 41, for example. The body 31 may be sufficiently rigid to avoidcollapsing upon application of suction or negative pressure. In someembodiments, a proximal end of the body 31 may be capped or sealed tomaintain the interior pressure, for example, as described above withrespect to FIG. 26D. A valve, plunger, or both may also be included. Inthis embodiment, the positioning device 31 defined a hollow central paththrough which material may pass while the positioning device 31 ispositioned within the lumen 52 (see FIG. 25 ).

With continued reference to FIGS. 25-26D projections 35 may be removedor vacuum may be released when the embedment device has embedded thetissue wall 50. The positioning device 31 may then be withdrawn from thelumen 52. As also noted above, the body 33 may be sufficiently rigid tomaintain the suction or negative pressure. In some embodiments, the body33 may also compress the embedment device 10 against the tissue wall.The body 33 may be collapsible for later removal when the embedmentstructure of the embedment device 10 has sufficiently embedded. Forexample, the body 33 may be mechanically collapsible, e.g., with hingesor slidable sections. In another example, the body 33 may be collapsibleby modification of the body 33, e.g., a shape change or shape memorymaterial that may be triggered to collapse or obtain a collapsibleconformation. In another embodiment, the positioning device 31 may beremoved without collapsing the body 33.

With continued reference to FIGS. 1-8 , in various embodiments, anembedment device 10 may be configured to prevent degree or depth ofmigration of the body 12 with respect to the tissue wall of a lumen. Forexample, the embedment device 10 may be configured such that an embeddedportion of the body 12 does not migrate completely through the tissuewall of the lumen.

An embedment device 10 may include an embedding conformation in whichoutward force, extension, or both is limited in time, distance, or both.For example, in the embedding conformation, the body 12 may applyoutward force against the tissue wall until a circumference or perimeterof the body 12 has reached a predetermined length or achieved apredetermined cross-section shape or dimension therein to obtain theembedded conformation. In another example, outward force may be appliedby a larger dimension of the body 12 that expands the correspondingdimension of the lumen. The body 12 may embed the lumen such that theembedded structure does not continue to apply outward force and thecorresponding dimension of the lumen decreases to a dimension less thanthe greater dimension of the body 12. The tissue defining the lumen maycover the body 12 or embedded portions thereof in the embeddedconformation. In some embodiments, the embedment device 10 limitsmigration by embedding in the tissue walls wherein the tissue lodging isused as support from potential migration.

FIG. 27 illustrates a magnified view of a portion of a body 12 of anembedment device (e.g., any of the embedment devices 10 described withrespect to FIGS. 1-8 & 25 ) comprising a physical block 49 to migration.For example, the body 12 includes wires 30 defining openings 32.Positioned between the openings is a physical block 49 to migrationcomprising a material of film that covers one or more openings. Thephysical block 49 provides a material expanse between adjacent openings32 that prevents the block 49 portion from embedding in a tissue wall orotherwise inhibits migration through the wall. The block 49 may includevarious dimensions, such as ⅛ inch or more, ¼ inch or more, ½ inch ormore, ¾ inch or more, or 1 inch or more, for example. The number andproximity of blocks 49 may vary. For example, blocks 49 may be arrangedat spaced intervals of a couple inches or more. In one example, a block49 is positioned at a distal portion, a central portion, and/or aproximal portion of the body.

FIGS. 32A & 32B illustrate magnified views of a portion of a body 12 ofan embedment device (e.g., which may include any embedment devicedescribed herein) including another configuration of a physical block 49to migration comprising an excess or expandable covering 53 extendingover one or more openings 32 formed between wires 30 of the meshstructure. The physical block 49 provides a material expanse over one ormore openings 32 that controls embedding depth or otherwise inhibitsmigration through the wall. The size of the block 49 may include variousdimensions, such as ⅛ inch or more, ¼ inch or more, ½ inch or more, ¾inch or more, or 1 inch or more, for example. The number and proximityof blocks 49 may vary. For example, blocks 49 may be arranged at spacedintervals of a couple inches or more. In some embodiments, blocks 49 maybe spaced apart by less than a couple inches, such as by 1 inch or less.In one example, a block 49 is positioned at a distal portion, a centralportion, and/or a proximal portion of the body. As introduced above, thematerial forming the covering 53 may be expandable and/or in excess ofthe area defined between the attachment points of the material and thewires 30. The excess material and/or expansion of the material allowsthe covered portion to embed to a depth wherein tissue ingrowth fillsthe available volume between the covering 53 and the covered wires 30and openings 32. Thus, ingrowth may result in billowing or bubbling ofthe material, allowing the wires 30 to embed only to where the mucosalsurface ingrowth meets the material. In one example, the excess orexpandable material between wires 30 limits penetration depth of thewires 30 before the submucosa. In various embodiments, the covering 53may be configured to allow a maximum ingrowth beneath the covering 53 ofbetween approximately 0.5 mm and approximately 2 mm, such asapproximately 0.5 mm, approximately 0.75 mm, approximately 1 mm,approximately 1.25 mm, approximately 1.5 mm, approximately 1.75 mm, orapproximately 2 mm. The covering 53 may attach to wires 30 forming aperimeter around single or multiple openings 32. In some embodiments,the covering attaches to wires 30 forming an outer perimeter aroundmultiple openings 32 in addition to wires 30 forming an inner perimeteraround one or more openings 30 within the outer perimeter.

FIGS. 28-30 illustrate another embodiment wherein the body 12 of anembedment device 10 includes covered portions or blocks 49 comprisingstripes 51. Various arrangements of stripes 51 may be used. FIG. 28illustrates an example of a body 12 including a plurality ofcircumferential stripes 51. One or more of the stripes 51 may extendaround the full circumference or only a portion thereof. FIG. 29illustrates an example of a body 12 including a plurality oflongitudinal stripes 51. One or more of the stripes 15 may extend thefull length of the body 12 or only a portion thereof. FIG. 30illustrates an example of a body 12 including a plurality of stripes 51extending along zig-zag paths. One or more of the stripes 51 may extendthe full length of the body 12 or only a portion thereof. In variousembodiments, stripes 51 may extend along the body 12 at other angles,such as diagonals, and/or may extend along multiple angled paths, whichmay include curved paths. The blocks 49 of the stripes 51 may comprisetight coverings, excess coverings, expandable coverings, or combinationthereof.

In various embodiments, an embedment device may include a bodycomprising two or more portions having different diameters. For example,embedded confirmations or expanded diameters may vary, providing variedembedment depth along the body. Different diameters may be used tocontrol depth of embedment. For example, in some configurations, one ormore of the portions may include covered portions or blocking. Forexample, portions having reduced diameters may include blocking, whichmay include full or partial blocking, e.g., staggered, stripes,intermittent, and/or patches. The blocking may prevent ingrowth oftissue to limit embedment depth of adjacent or uncovered portions of thebody.

FIG. 31 illustrates an embodiment wherein the embedment device 10includes a body 12 comprising multiple diameters along its length. Thebody 12 includes a first portion 13 having a first diameter, a secondportion 15 having a second diameter, and a third portion 17 having athird diameter. The second diameter is greater than the first and thirddiameters. In one example, the first and third diameters areapproximately the same. The body 12 may comprise a mesh or otherembedding structure as described herein. The first 13 and third portions17 may include covering material or blocking 49, which may include fullor partial blocking, e.g., staggered, stripes, intermittent, and/orpatches, and/or expandable and/or excess material (see, e.g., FIGS. 32A& 32B) to limit or prevent embedment of the first 13 and third portions17. In some embodiments, larger diameter portions may include one ormore blocking areas. The variation in diameter between the first and/orthird portions 13, 17 and the second portion 15 may vary based on adesired embedded depth of the second portion 15. For example, thediameters of the first and/or third portions 13, 17 and the secondportion 15 may differ by approximately 0.5 mm to approximately 2 mm,such as approximately 0.5 mm, approximately 0.75 mm, approximately 1 mm,approximately 1.25 mm, approximately 1.5 mm, approximately 1.75 mm,approximately 2 mm, or any distance therebetween. In some embodiments,the body 12 may include other diameter configurations. For example, insome examples, the body 12 includes first and second portions havinglarger diameters than a third portion or staggered diameters. In someembodiments, the body 12 may include more than three portions havingvaried diameters between portions. For example, four, five, six, seven,or more portions may be used. Diameters may be aligned such that smalldiameter portions are positioned between portions having largerdiameters, for instance.

As introduce above, in various embodiments, the embedment device 10 maybe configured to prevent a tissue wall defining a lumen from expandingaway from a force applied to the wall, which may be outward, e.g.,pushing, or inward directed, e.g., pulling, forces. For example, thebody 12 may provide an embedded scaffold that limits expansion orcontraction of the wall to pushing or pulling forces. The body 12 of theembedment device 10 may have a maximum cross-section dimension orperimeter dimension, e.g., circumference. In some embodiments, the body12 of the embedment 10 device may lack rigidity in shape such that thelumen may contract inwardly when the embedment structure is embedded.However, in one embodiment, the body 12 of the embedment device 10 maybe rigid at one or more portions to limit inward contractions. In someexamples, the body 12 in the embedding or embedded conformation definesa rigid circumference, perimeter, cross-section shape, diameter or otherdimension. In these or other examples, the body 12 in the embedding orembedded conformation defines a maximum circumference, perimeter, ordiameter having little to no practical range of increase. In variousembodiments, the maximum circumference, perimeter, diameter or otherdimension may be rigid or flexible in cross-section. In one embodiment,one or portions of the circumference, perimeter, diameter or otherdimension are rigid while one or more other portions are flexible. Insome examples, portions may have differential rigidity and flexibility.For example, a body 12 comprising threaded flexible string or mesh mayallow approximately native flexibility with respect to the cross-sectionof the lumen but may limit the maximum circumference or perimeter thetissue wall may achieve.

In one embodiment, an embedment device 10 for reinforcement of thegastrointestinal tract may include a body 12 dimensioned to limitexpansion to a cross-section dimension that is less than a cross-sectiondimension, such as a maximum cross-section dimension, defined by theadventitia, which forms the outermost layer of the gastrointestinaltract. The body 12 may include an enlarged maximum cross-sectiondimension that corresponds to the cross-section dimension in theembedding and embedded conformations or may include an embeddingconformation wherein the cross-section dimension is less than themaximum cross-section dimension and the body 12 is biased to expand tothe maximum cross-section dimension to transition to the embeddedconformation.

FIG. 6 provides an end view of an embedment device 10 according tovarious embodiments. The embedment device 10 includes one or moreattachment structures 60 comprising projections 62 that extend outwardlyabout a perimeter of the body 12. In various embodiments, attachmentstructures 60 may be referred to as positioning devices attached to theembedment device 10 or body 12 thereof. For example, attachmentstructures 60 may be configured to assist in initial attachment orstability of the embedment device 10 at the target site. In one example,attachment structures 60 may include projections 62 configured topenetrate tissue along a wall defining a lumen. Projections 62 mayinclude barbs, hooks, or straight projections such as pins, for example.Additionally or alternatively, attachment structures 60 may includesutures (not shown). For example, a body 12 of an embedment device 10may be sutured or sewn to a tissue wall.

In some examples, the attachment structures 60 may be absorbable such asabsorbable projections, absorbable barbs, absorbable sutures, orabsorbable hooks. Attachment structures 60 may be positioned at one ormore locations along the body 12. For example, one or more rows of barbsor hooks may be positioned along a length or about a perimeter of thebody 12. In various embodiments, attachment structures 60 aredimensioned to not extend completely through the tissue wall definingthe lumen. For example, a length of the attachment structures 60 may belimited to less than a thickness of a tissue wall as to not puncturethrough the wall.

Attachment structures 60 may assist in positioning of the embedmentdevice 10 at the target site prior to embedment. The embedment device 10or body 12 may subsequently at least partially embed the tissue wall toreinforce and strengthen the wall. In some embodiments, an embedmentdevice 10 may be attached at a target site via attachment structures 60and an anchor device may be anchored to the target site in a singleprocedure. In other embodiments, an embedment device may be attached ata target site via attachment structures 60 and an anchor device may beanchored to the target site in a subsequent procedure. The subsequentprocedure may take place the next day or sometime thereafter. In someinstances, the subsequent procedure may take place after the embedmentdevice 10 has at least partially or completely embedded the tissue.

Embodiments of the embedment device 10 may embed and therein reinforce atissue wall of the gastrointestinal tract. For example, thegastrointestinal tract generally contains four tissue layers. Startingfrom the innermost layer and moving outward, the gastrointestinal tractincludes the following layers: mucosa, submucosa, muscularis propria,and the adventitia or serosa, which is the outermost layer. In variousembodiments, the embedment device may embed within the mucosa, such aswithin the lamina propria, muscularis mucosa, or both. In furtherembodiments, the embedment device embeds within the submucosa. Theembedment device may embed completely within the mucosa, submucosa, orextend within both. In one embodiment, the embedment device 10 orportion thereof may extend to or within the muscularis propria.

In various embodiments, the embedment devices 10 described herein,including those illustrated in FIGS. 1-5, 7 & 8 , may include attachmentstructures 60 or positioning devices along a perimeter of the body 12.

In some embodiments, the embedment device comprises a first portionconfigured to embed a tissue wall and a second portion configured toextend within the lumen. In various embodiments, an embedment device 10includes a body 12 comprising a double wall configuration or aconfiguration having an outer portion positioned to compress against andembed a tissue wall defining a biological lumen. The body 12 may furtherinclude an inner positioned portion attached to the outer positionedportion configured to provide a scaffold or coupling platform onto whichanother device may couple to anchor within the lumen.

FIG. 7 illustrates an example of an embedment device 10 having a body 12comprising an outer portion 76 configured to embed a tissue wall and aninner portion 74 comprising a coupling platform 80. The body 12 includesa multi-layer mesh configuration wherein the outer portion 76 comprisesan outer layer configured to embed a tissue wall and the inner portion74 comprises an inner layer 76. The inner layer may be configured toremain at least partially unembedded in use.

The outer portion 76 may include an embedment structure configurationconsistent with the present disclosure to embed the tissue wall. Forexample, the outer portion 76 may include threaded wire, coil, injectedpolymer, or combinations thereof. In the illustrated embodiment, theouter portion 76 comprises a mesh structure similar to that describedwith respect to FIG. 1 .

The coupling platform 80 provides a platform onto which another device,such as an anchor device, which may or may not include a medical device,may couple. For example, the coupling platform 80 includes one or morecouplings 82 configured to couple to one or more corresponding couplingsof another coupling platform, which may comprise a medical device havingcorresponding couplings and/or coupling surfaces for coupling tocouplings 82. A coupling 82 may refer to mating surfaces, structureshaving male and female relationships as well as adhesive or attractivesurfaces, suction, sliding, compression fit, interlocking relationships,and combinations thereof with respect to corresponding couplings and/orcoupling surfaces thereof. Couplings 82 may comprise one or more ofopenings, slots, grooves, rails, latches, flanges, rims magnets,projections, lips, sockets, pins, clips, hooks, loops, or ball andsocket configurations, for example. Any of which may comprise a couplingsurface. In various embodiments, a coupling surface may includeinterlocking or touch fasteners, e.g., hook-and-loop, suction ormicro-suction structures, adhesives, magnets, or other couplingstructures in which to couple a corresponding coupling. As shown, theone or more couplings 82 include rails and openings. Correspondingcouplings such as latches, projections, e.g., hooks, may couple to therails or within openings. As noted above, the rails may include couplingsurfaces incorporating interlocking or touch fasteners, adhesives,magnets, or magnet attractive material.

The outer portion 76 may be configured to apply outwardly directed forcealong the tissue wall to embed therein as described above and elsewhereherein. In further embodiments, the outer portion 76 may includemultiple layers of mesh configured to embed the tissue wall.

The inner and outer portions 74, 76 may be coupled by one or moreconnectors (not visible). The one or more connectors may be dimensionedto provide a suitable distance between the outer portion 76 and thecoupling platform 80 of the inner portion 74. The one or more connectorsmay also be dimensioned to provide a suitable distance between thecoupling platform 80 and tissue wall when the outer portion 76 embedsthe wall. For example, the one or more connectors may prevent thecoupling platform 80 from embedding within the tissue wall, which mayinclude not completely embedding within the tissue wall. The one or moreconnectors may comprise wires extending between the outer portion 76 andthe inner portion 74. The one or more connectors may be may be rigid orflexible. In one example, a connector includes threaded wire. In anotherexample, the inner portion 74 and outer portion 76 may fold into eachother at one or both ends of the body 12.

In some configurations, the coupling platform 80 or connector includes acover or shroud that extends between a perimeter of the outer portion 76and the inner portion 74. Such an embodiment may find beneficialapplication when it is desired to limit or prevent passage through thelumen between the coupling platform 80 and the outer portion 76 ortissue wall. In one embodiment, the outer portion 76 includes a cover orshroud. Similarly, the anchor system 2 may include an anchor devicehaving a lip or flange about a perimeter to limit or prevent passage ofmaterial along the perimeter of the lumen.

FIG. 8 illustrates an embodiment of an embedment device 10 having agenerally tubular body 12 comprising an outer portion 76 configured toembed a tissue wall and an inner portion 74 comprising a couplingplatform 80. The outer portion 76 may include an embedment structureconfiguration consistent with the present disclosure to embed the tissuewall. For example, the outer portion 76 may include threaded wire, coil,injected polymer, or combinations thereof. In the illustratedembodiment, the outer portion 76 includes a wire mesh forming an outerperimeter of the body 12 and is configured to apply outwardly directedforce against a tissue wall defining a lumen in a manner similar to thatdescribed with respect to FIG. 1 .

The coupling platform 80 includes one or more couplings 82 comprising arail. The rail extends around an inner perimeter and forms a ringconfigured to position within the lumen, inward of the tissue wall, whenthe outer portion 76 embeds the tissue wall. The coupling platform 80provides a platform onto which another device having a coupling platformcomprising one or more corresponding couplings may couple. For example,an anchor device, which may or may not include a medical device,comprising a coupling platform having one or more couplings comprisinglatches or projections, e.g., hooks, may couple to the rail. Othercoupling arrangements may be used, such as any of those describedherein. For example, the coupling platform 80 may include a coupling 82incorporating magnets, hook-and-loop, suction or micro-suctionstructures, or adhesive configured to assist in coupling to acorresponding coupling. In some examples, such couplings 82 includecoupling surfaces incorporating magnets, hook-and-loop, suction ormicro-suction structures, adhesives, or magnet attractive materials. Inanother example, one or more additional rails may be included toincrease coupling points or to provide flexibility in coupling location.Additional rails may further form one or more additional couplings 82such as openings, gaps, slots, or grooves into which correspondingcouplings such as pins, clips, lips, rails or combinations thereof maycouple. Other configurations may also be used such as ball and socketcouplings. In any of the coupling configurations, magnets or magnetattractive materials may be used, such as incorporated with one or moreparticular coupling structures or separately.

One or more connectors 88 couple the outer portion 76 and the couplingplatform 80. The one or more connectors 88 may be dimensioned to providea suitable distance between the outer portion 76 and the couplingplatform 80 of the inner portion 74 such that the coupling platform 80does not completely embed the tissue wall, which may include notcontacting the tissue wall. The one or more connectors 88 may comprisewires, which may be rigid or flexible. In one example, the connectors 88comprise threaded wire. In some configurations, the body 12 may includea cover or shroud as described above with respect to FIG. 7 .

FIG. 33 illustrates an embodiment of an embedment device 10 having agenerally tubular body 12 comprising an outer portion 76 configured toembed a tissue wall and an inner portion 74 comprising a couplingplatform 80. The outer portion 76 may include an embedment structureconfiguration consistent with the present disclosure to embed the tissuewall. For example, the outer portion 76 may include threaded wire, coil,injected polymer, wire mesh, other structure, or combinations thereof.In the illustrated embodiment, the outer portion 76 includes a wire meshforming an outer perimeter of the body 12 and is configured to applyoutwardly directed force against a tissue wall defining a lumen in amanner similar to that described with respect to FIG. 1 .

The coupling platform 80 includes one or more couplings 82 comprisingprojections that extend inwardly from the outer portion 76 and areconfigured to position within the lumen, inward of the tissue wall, whenthe outer portion 76 embeds the tissue wall. The coupling platform 80provides a platform onto which another device having a coupling platformcomprising one or more corresponding couplings may couple. For example,an anchor device, which may or may not include a medical device,comprising a coupling platform having one or more couplings comprisinglatches, clips, or projections, e.g., hooks, may couple to the coupling82. Other coupling arrangements may be used, such as any of thosedescribed herein. For example, the coupling platform 80 may include acoupling 82 incorporating magnets, hook-and-loop, suction ormicro-suction structures, or adhesive configured to assist in couplingto a corresponding coupling. In some examples, such couplings 82 includecoupling surfaces incorporating magnets, hook-and-loop, suction ormicro-suction structures, adhesives, or magnet attractive materials. Theillustrated couplings 82 include projecting surfaces, including curvedsurfaces, configured to interface and thereby couple with correspondingcouplings disposed on another coupling platform, which may comprise ananchor device or an anchor device including a medical device. Thecorresponding couplings may include projections, rails, curved surfaces,or other structures configured to engage and/or curve around thecouplings 82 projecting from the body 12 of the embedment device. In oneembodiment, the one or more couplings 82 comprise one or more loops ontowhich corresponding couplings comprising projections, hooks, latches,clips, or other structures may couple. The loops may be may defineopenings orientated vertically, or proximally/distally with respect to acoupled orientation of the device, to receive vertically orientatedportions of corresponding coupling structures. For example, when acorresponding coupling platform is delivered into the lumen, adjacent tothe coupling platform 80 of the embedded device 10, distal movement ofthe corresponding coupling platform may assist in positioning thecorresponding couplings within or against the loops to anchor thecorresponding coupling platform relative to the portion of the tissuewall within which the embedded device 10 is embedded. Otherconfigurations may also be used such as ball and socket couplings. Inany of the coupling configurations, magnets or magnet attractivematerials may be used, such as incorporated with one or more particularcoupling structures or separately.

With reference again to FIG. 23 , the anchoring system 2 may include adelivery device 20 configured to deliver the embedment device 10. Forexample, the embedment device 10 may be delivered utilizing a deliverydevice 20 employing a minimally invasive technique such as keyholesurgery, e.g., endoscopic or laparoscopic, through a natural bodyorifice, such as the mouth, anus, ear canal, nose, or vagina, naturalorifice transluminal endoscopic surgery, or other suitable procedure. Inone example, delivery of the embedment device 10 to the esophagus 136may include passing a delivery device tube or sheath 22 through themouth and into the esophagus 136. In further embodiments, the embedmentdevice 10 may be delivered into the stomach 138 or through the stomach138 and into the duodenum 140.

The delivery device 10 may include a proximal end 68 for directing andmanipulating a rigid or flexible sheath 22 having a distal end 70 forcoupling to and/or manipulating the embedment device 10. In someembodiments, the distal end 70 may include a retainer 29 to retain theembedment device 10 in a delivery conformation. The delivery device 20may be configured to allow release of the embedment device 10 at thetarget site 24. Release of the embedment device 10 may include actuatingthe delivery device 10 to release a clamp, grasper, or expel theembedment device 10 from distal pocket or a distal end 70 of thedelivery sheath 22, for example. In the illustrated embodiment, aplunger 28 may be used to urge the embedment device 10 from the distalend 70 of the sheath 22. In some embodiments, release of the embedmentdevice 10 at the target site 24 may accompany release of a retainer toallow the embedment device 10 to transition to an embeddingconformation. For example, release may include removal of the embedmentdevice 10 from a restricted volume, such as expelling the embedmentdevice 10 from an opening in a tube or pocket within the sheath 22, therelease of a clamp, removal of one or more pins, relatively sliding abrace or bracket and the embedment device 10 to remove the coupling, orcombinations thereof. In some embodiments, a separate device may be usedto release the retainer. In some embodiments, the embedment device 10stably maintains a delivery conformation without utilization of aretainer that may be associated with the delivery device or a separateretainer. For example, the embedment device 10 may comprise a shapechange or shape memory material configured to change shape or obtain amemory shape comprising an embedding or embedded conformation. In oneembodiment, the delivery device does not include a retainer.

The delivery device 20 or a separate device may assist in transitioningthe embedment device 10 from the delivery conformation to the embeddingconformation. For example, as introduced above, the delivery device 20may release the embedment device 10 from a restrictive volume or releasea retainer, reducing conformational stresses to allow the embedmentdevice 10 to transition to the embedding conformation and applyoutwardly directed force along one or more portions of the tissue wall.In some embodiments, the embedding conformation corresponds to theembedding conformation such that the transition from the deliveryconformation to the embedding conformation results in the embedmentdevice obtaining its maximum embedded dimension. Embedment devices 10including shape change or shape memory materials may be selected torespond to various environmental conditions such as temperature. Thedelivery device 20 or a separate device may be configured to establishan environmental condition, e.g., induce an electromagnetic field,impart an electrical current, or generate an electromagnetic field, tosupport transition to the embedding or embedded conformation.

The delivery device 20 or a separate device may assist in initialpositioning or attachment of the embedment device 10. For example, withrespect to attachment structures 60 comprising sutures, a deliverydevice 20 or another device may be used to apply the sutures.

In various embodiments, a delivery device (not shown) includes asyringe, which may include a plurality of syringes. The syringes may beused to inject polymer.

With reference to FIGS. 9-14 , and as introduced above, an anchoringsystem 2 may include an anchor device 90 configured to stably anchorwithin the lumen. While not illustrated in FIGS. 9-14 , anchor devices90 may include medical devices. For example, a medical device may beintegrated with an anchor device 90 to anchor within a lumen. In variousembodiments, an anchor device 90 is configured to couple one or moremedical devices. In some examples, coupled anchor and medical devicesmay be delivered to the target site together. In further examples, theanchor device 90 may provide a convenient platform onto which one ormore medical devices may be implanted, removed, or both in situ.

An anchor device 90 may include a body 92. The body 92 may comprise oneor more annular rings, mesh, helical coil, straight or curved wire, forexample. The body 92 may be constructed of metals, alloys, polymers,ceramics, or other suitable materials for locating within a biologicallumen. In various embodiments, an anchor device 90 comprises a body 12having a rigid shape. In one embodiment, the anchor device comprises abody 12 having a flexible shape. In this or another embodiment, the body12 comprises a shape that is elastic, resilient, or both. The body 12may include a delivery conformation wherein the body 12 is reduced in atleast one dimension relative to an anchor conformation. The deliveryconformation may arise from compression or deformation of the body 12relative to the anchor conformation in a manner similar to thatdescribed herein with respect to the embedment device. For example, theanchor device 90 may be retained by a retainer during delivery or may bedeformed for delivery and then released to decompress or induced toreform into the anchor conformation when delivered to the target site.

An anchor device 90 may include one or more anchors 96 structured toanchor to the tissue wall. Anchors 96 may comprise projections extendingor extendable from the body 92 positioned to engage the tissue wall. Inapplication, anchors 96 may engage a tissue wall having an embedmentdevice embedded or embedding therein. The anchors 96 may typicallyengage or penetrate the tissue wall to anchor the anchor device 90. Invarious embodiments, anchors 96 are dimensioned to penetrate tissuewalls but not to puncture completely through the wall and therebytraverse the wall to an external side thereof. In some embodiments, theanchor conformation may apply outwardly directed force on the tissuewall of the lumen to assist in engagement of anchors 96.

An anchor 96 may be structured to engage tissue when the anchor device90 is oriented such that the projections are positioned along an outerportion of the body 92, adjacent to the tissue wall. For example,projections, together or independently may include outwardly directededges, such as points, to penetrate tissue. The outwardly directed edgesmay include edges positioned at angles having radial, distal, orproximal components. For example, distally directed edges may bepositioned to engage tissue when the anchor device 90 is moved distally.Proximally directed edges may be positioned to engage tissue when theanchor device 90 is moved proximally, while radially directed edges maybe positioned to engage tissue when the anchor device 90 is move in aradial direction, which may include radial directions having proximal ordistal components. In some examples, projections are structured tohinder ease of extraction from tissue. For example, projections mayinclude proximal extensions, distal extensions, or lateral extensionsthat extend within tissue and therein hinder extraction of theprojection. In some embodiments, projections may include hooks havingbends structured to hook tissue within the hook throat. In someembodiments, projections may include barbs, which may be positionedadjacent to projection edges. In some embodiments, a hook may include abarb, which may be located adjacent to an edge, along a bend, or along ashank of the hook.

As introduced above, anchor devices 90 may be configured to anchor totissue walls embedded with an embedment device. The embedment device mayallow for stronger forces to be applied than the native structure couldresist. For examples, anchors 96 that penetrate tissue may be preventedfrom proximal, distal, or circumferential tearing along the tissue wallby an embedded device. The embedded device may provide improveddistribution of tearing force along the tissue in which it embeds. Forexample, in addition to or alternatively to anchors 96 that penetratetissue, such as hooks, barbs, and straight projections, anchor devices90 may anchor to a reinforced lumen via direct pressure on the tissuewall. That is, the embedment device may prevent or limit the ability ofthe tissue walls along the reinforced portion of the lumen to expandaway from the direct, outward, pressure. Direct pressure may be providedin a manner similar to that described herein with respect to theembedment device. For example an expandable mesh or coil may be used,which may primarily hook onto the body of the embedded device. Limitingthe ability of the lumen to expand may also limit radial tearing fromhooks or undesired extraction of straight projections due to excessivelumen expansion. Anchors 96 may also include magnets providing magneticattraction to the embedment device or may include magnetic attractivematerials configured to attract to magnet portions of an embeddeddevice. Attachment with anchors 96 including magnetic attraction with anembedded device may include anchors that penetrate tissue walls or thatcompress against but do not penetrate tissue walls or interactmechanically or geometrically with the embedded structure. In oneexample, an anchor device comprises expandable tubing configured toexpand to apply direct pressure on the reinforced tissue wall to therebyanchor therein. The expandable tubing may be biased to expand or mayinclude magnetic attraction with an embedment device that expands thetubing to the approximate dimensions of the lumen.

The anchor device 90 illustrated in FIG. 9 includes a body 92. The body92 is formed or formable into an annular cross-section. The body 92 maycomprise metal, alloy, polymer, fabric, ceramic, or combinationsthereof, for example. The body 92 may be rigid, flexible, elastic, orresiliently elastic. In some embodiments, the body 92 may comprise ashape change or shape memory material such as nitinol. One or moreanchors 96 comprising are located along a perimeter of the body 92 andare positioned or positionable outwardly to engage tissue of a lumenwall. The anchors 96 include hooks to hook tissue. Other anchorconfigurations such as straight projections or barbs may also be used.The hooks are positioned between an upper rim 98 and a lower rim 99. Ina further or another embodiment, the body 92 includes one or moreanchors 96 comprising magnets or magnet attractive materials that may ormay not penetrate, e.g., puncture, into tissue.

The anchor device 90 illustrated in FIG. 10 includes a body 92comprising a mesh structure. The mesh structure may be similar to thatdescribed above with respect to FIG. 1 . The body 96 is formed orformable into an annular cross-section. The body 92 may comprise metal,alloy, polymer, fabric, ceramic, or combinations thereof, for example.The body 92 may be rigid, flexible, elastic, or resiliently elastic. Insome embodiments, the body 92 comprises a shape change or shape memorymaterial such as nitinol. In one embodiment, one or both of an upper rim98 or lower rim 99, corresponding to proximal and distal rims in use,may comprise a rigid or resiliently elastic conformation in use while acentral portion of the body 92 comprises a flexible material. In anotherembodiment, the central portion of the body 92 may comprise a rigidmaterial in use. One or more anchors 96 are located along a perimeter ofthe body 92 and are positioned or positionable outwardly to engagetissue of a lumen wall or the embedded structure, which may includeembedded structures that are embedded materials such as injectedpolymer. The anchors 96 include hooks to hook tissue or the embeddedstructure. Other anchor configurations may be used. As illustrated, thebody 92 includes hooks positioned along the upper rim 98 and lower rim99. In a further or another embodiment, the body 92 includes one or moreanchors 96 comprising magnets or magnet attractive materials that may ormay penetrate, e.g., puncture, into tissue.

The anchor device 90 illustrated in FIG. 11 includes a body 92 formed orformable into an annular cross-section. The body 92 may comprise metal,alloy, polymer, fabric, ceramic, or combinations thereof, for example.The body 92 may be rigid, flexible, elastic, or resiliently elastic. Insome embodiments, the body 92 may comprise a shape change or shapememory material such as nitinol. One or more anchors 96 are locatedalong a perimeter of the body 92 and are positioned or positionableoutwardly to engage tissue of a lumen wall. The anchors 96 include hooksconfigured to hook tissue. Other anchor configurations such as barbs orstraight projections may be used. In a further or another embodiment,the body 92 includes one or more anchors 96 comprising magnets or magnetattractive materials that may or may not penetrate, e.g., puncture, intotissue.

The anchor device 90 illustrated in FIG. 12 comprises a body 92 formedor formable into an annular cross-section and extending along in a wavepattern. The body 92 may comprise metal, alloy, polymer, fabric,ceramic, or combinations thereof, for example. The body 92 may be rigid,flexible, elastic, or resiliently elastic. In some embodiments, the body92 may comprise a shape change or shape memory material such as nitinol.One or more anchors 96 are located along a perimeter of the body 92 andare positioned or positionable outwardly to engage tissue of a lumenwall. The anchors 96 include hooks configured to hook tissue. Otheranchor configurations such as barbs or straight projections may be used.In a further or another embodiment, the body 92 includes one or moreanchors 96 comprising magnets or magnet attractive materials that may ormay not penetrate, e.g., puncture, into tissue.

The anchor device 90 illustrated in FIG. 13 includes a body 96comprising an inflatable balloon. The body 92 has an annular shapedefining a central hole similar to a doughnut. The balloon may beinflated at a target site to compress against a tissue wall. Theillustrated anchor device 90 may anchor by application of outwardlydirected pressure and does not include anchors, however, in someembodiments, anchors as described herein may be used, e.g., locatedalong a perimeter of the body 92.

As introduced above with respect to FIGS. 7 & 8 , in some embodiments,an anchor device 90 may include one or more coupling platforms 100configured to couple to another coupling platform, such as a couplingplatform associated with another anchor device fitted with a medicaldevice. The coupling platform 100 may be similar to the couplingplatform and variations thereof described above with respect to FIGS. 7& 8 and elsewhere herein. The anchor device 90 may include one or morecouplings 102 comprising openings, slots, grooves, rails, latches,magnets, coupling surfaces, lips, ball, sockets, pins, clips, hooks,balls, or combinations thereof. For example, the anchor device 90 mayinclude a coupling platform 100 having a coupling 102 comprising acoupling 102 surface configured to couple to a corresponding coupling,which may include a coupling surface, of another anchor device, such asa ledge, lip, or flange. In some embodiments, the coupling 102 mayinclude a textured surface, magnets, or adhesive as described herein.The surface may include structures configured to interlock or touchfasteners, e.g., hook-and-loop, suction or micro-suction structures,adhesives, magnets, or other coupling structures in which to couple acorresponding coupling.

As an example, the anchor device 90 illustrated in FIG. 9 may include acoupling platform 100 comprising a coupling 102 along a surface of anupper 98 or lower 99 rim of the body 92. The surface may include atextured surface, magnets, magnet attractive material, interlocking,touch fasteners, or adhesive, as described above and elsewhere herein.

With reference again to the anchor device 90 illustrated in FIG. 10 ,the body 92 may include a coupling platform 100 comprising one or morecouplings 102. For example, one or more couplings 102 comprising railsor wires of the mesh may provide surfaces onto which a correspondingcoupling such as a hook, clip, or latch may couple. Couplings 102 mayalso include openings between the rails or wires into whichcorresponding couplings such as projections, pins, or clips may couple.In the illustrated embodiment, a diameter of a region of the bodybetween the upper and lower rims 98, 99 is reduced providing a moreaccessible coupling 102 to which a corresponding coupling may attach. Inthis or other embodiments, the coupling 102 may incorporate magnets,magnet attractive material, interlocking fastener structures such astouch fasteners, or other coupling configurations described herein.

The embodiments illustrated in FIGS. 11 & 12 may also include a couplingplatform 100 comprising a coupling 102 including a rail or wire ontowhich a corresponding coupling such as a hook, clip, or latch maycouple. In these or other embodiments, the coupling 102 may incorporatemagnets, magnet attractive material, interlocking fastener structuressuch as touch fasteners, or other coupling configurations describedherein.

As another example, the balloon illustrated in FIG. 13 may also includea coupling platform 100 comprising a coupling 102. For example, thecoupling 102 may include a surface defined along an upper or lower rim98, 99 of the body 92. The surface may couple to a corresponding surfaceutilizing adhesive, magnets, magnet attractive material, interlockingfastener structures such as touch fasteners. The balloon may also beconfigured with another coupling as described above with respect toFIGS. 9-12 .

Another embodiment of an anchor device 90 similar to FIG. 9 includinganother coupling platform 100 is illustrated in FIG. 14 . In thiscross-section depiction, the body 92 includes a coupling platform 100comprising a coupling 102 including a groove or slot onto which acorresponding coupling such as a clip, notch, tab, or other protrusionmay be received. In this or other embodiments, the coupling 102 mayincorporate magnets, magnet attractive materials, interlocking fastenerstructures such as touch fasteners, or other coupling configurationsdescribed herein. Similar to the embodiment described with respect toFIG. 9 , the upper or lower rims 98, 99, which may correspond to aproximal and a distal rim in use, may also comprise a coupling 102 foruse either together with or independently of the slot.

As introduced above, the anchor system 2 may include an anchor deviceincluding or configured to couple with a medical device. The medicaldevice may be any device to be anchored to a target site within abiological lumen, such as those identified herein. In some embodiments,an anchor device 90 includes one or more coupling platforms 110configured to couple to another coupling platform, such as couplingplatforms associated with an embedment device or another anchor device.FIGS. 15-22B illustrate various embodiments of anchor devices 90including a medical device 110. The anchor devices 90 include one ormore coupling platforms 110 comprising one of more couplings 112configured to couple to a corresponding coupling of another couplingplatform, which may be a coupling platform 80 or variation thereofassociated with an embedment device 10, such as those described withrespect to FIGS. 7 & 8 and elsewhere herein, or a coupling platform 100or variation thereof associated with an anchor device 90, such as thosedescribed with respect to FIGS. 9-14 and elsewhere herein.

Couplings 112 may generally be position along an outer perimeter of thebody 92 or rim 98, 99, which may include a flange, for example. Examplecouplings 112 include projections, openings, slots, grooves, rails,latches, magnets, coupling surfaces, lips, ball, sockets, pins, clips,hooks, balls, or combinations thereof. Couplings 112 may includesurfaces that may include textures, magnets, magnetized material,adhesives, interlocking structures or touch fasteners.

The anchor devices 90 illustrated in FIGS. 15-22B include medicaldevices 120 comprising gastric bypass stents. The stent includes asleeve 122 having a proximal end 124 to anchor in the esophagus and adistal end 126 to position in the duodenum or beyond. The sleeve 122will typically comprise an impermeable material that prevents passage ofmaterial between the interior lumen of the sleeve 122 and the exteriorenvironment.

The medical device 120, or sleeve 122 in the illustrated embodiments,may be attached or otherwise coupled to the anchor device 90 comprisingthe coupling platform 110 using adhesives, fasteners, or other suitabletechnique. In one example, Velcro is used to couple the sleeve 122 tothe anchor device 90.

The anchor device 90 device illustrated in FIG. 15 includes a couplingplatform 110 including one or more couplings 112 comprising projectionsextending outwardly along a perimeter of the anchor device body 92,adjacent to an upper rim 98. The projections may be structured to bereceived within a coupling of another coupling platform, such as anopening, which may include a slot or groove, e.g., an opening of acoupling platform illustrated in FIGS. 7, 10, 14 .

The projections may comprise metal, alloy, or polymer, such as siliconesand plastics. The projections may be rigid to maintain coupling afterbeing received within the opening. In some embodiments, one or moreprojections may be resiliently bendable or hinged such that theprojections may be pulled past a surface defining an opening andthereafter project into the opening. In another embodiment, one or moreprojections may comprise a shape change or shape memory material such asnitinol. For example, the anchor device 90 may be delivered or otherwisepositioned with respect to another coupling platform with the projectionin a flexible or deformed state. When properly positioned relative tothe opening, the projection may be induced to change or obtain a memoryconformation wherein the projection projects into the opening. In someembodiments, the projections may comprise a coupling surface. Thesurface may include coupling features configured to assist in couplingor maintaining coupling such as adhesives, interlocking or touchfastener structures, e.g., hook-and-loop, suction or micro-suctionstructures, magnets or magnetic attractive materials. The couplingfeatures may interact with surfaces of corresponding couplings such assurfaces defining openings, see, e.g., FIGS. 7, 10, 14 , or surfacessuch as a rim or other body surface, see, e.g., FIGS. 7-14 , configuredto couple to magnetic attractive materials or magnets of a couplingplatform of an anchor device.

The anchor device 90 device illustrated in FIG. 16 includes a couplingplatform 110 including one or more couplings 112 comprising a flangeextending outwardly along a perimeter of the anchor device body 92,adjacent to an upper rim 98. The flange may be structured to be receivedwithin a coupling of another coupling platform, such as an opening,which may include a slot or groove, e.g., an opening of a couplingplatform illustrated in FIGS. 7, 10, 14 . The flange may comprise metal,alloy, or polymer, such as silicones and plastics. The flange may berigid to maintain coupling after being received within the opening. Insome embodiments, multiple flanges may be positioned along the body 92.In one embodiment, the flange is resiliently bendable or hinged suchthat the flange may be pulled past a surface defining an opening andthereafter project into the opening. In another embodiment, the flangecomprises a shape change or shape memory material such as nitinol. Forexample, the anchor device 90 may be delivered or otherwise positionedwith respect to another coupling platform with the flange in a flexibleor deformed state. When properly positioned relative to the opening, theflange may be induced to change or obtain a memory conformation whereinthe flange projects into the opening. In some embodiments, the flangemay comprise a coupling surface. The surface may include couplingfeatures configured to assist in coupling or maintaining coupling suchas adhesives, interlocking or touch fastener structures, e.g.,hook-and-loop, suction or micro-suction structures, magnets or magneticattractive materials. The coupling features may interact with surfacesof corresponding couplings such as surfaces defining openings, see,e.g., FIGS. 7, 10, or 14 , or surfaces such as a rim or other bodysurface, see, e.g., FIGS. 7-14 , configured to couple to magneticattractive materials or magnets of a coupling platform of an anchordevice.

The anchor devices 90 illustrated in FIGS. 17 & 18 each include acoupling platform 110 including one or more couplings 112 comprisingprojections. The projections include clips that extend outwardly from aperimeter of the implant device. The clips may comprise metal, alloy, orpolymer. The clips may be resiliently bendable configured to compressinwardly and then decompress outwardly to extend into a correspondingopening of another coupling platform, see, e.g., FIGS. 7, 10, 14 . Forexample, the coupling platforms 110 illustrated in FIGS. 17 & 18 maycouple to a coupling platform of an embedment device or anchor deviceillustrated in FIGS. 7, 10, or 14 by positioning clips into an openingof the respective coupling platform. In various embodiments, the clipsmay comprise stainless steel or a shape change or memory material suchas nitinol configured to obtain a clip conformation to extend into anopening. The clips illustrated in FIG. 17 are positioned adjacent to anupper rim 98 and have a bend located substantially midway,longitudinally, between two legs 114 a, 141 b. The clips illustrated inFIG. 18 also include a bend located between two legs 114 a, 114 b butthe bend is located more proximal to an upper leg 114 a closest to theupper rim 98. In other embodiments, clips may include multiple bends. Insome embodiments, the clips may be sized to press fit within openings tolimit longitudinal, lateral, or rotational movement. In one example,clips are spaced apart to correspond with spacing of openings ofcorresponding couplings such that rotation is prevented by a boundary ofone or more openings that couple to the clips.

The anchor device 90 device illustrated in FIG. 19 includes a couplingplatform 110 including one or more couplings 112 comprising projectionsextending outwardly along a perimeter of the anchor device body 92. Theprojections may be structured to be received within a coupling ofanother coupling platform, such as an opening, which may include a slotor groove, e.g., an opening of a coupling platform illustrated in FIGS.7, 10, 14 . The projections may comprise metal, alloy, or polymer, suchas silicones and plastics. The projections may be rigid in order tomaintain coupling after being received within the opening. In someembodiments, the projections comprise a surface including couplingfeatures configured to assist in coupling or maintaining coupling suchas adhesives, interlocking or touch fastener structures, e.g.,hook-and-loop, suction or micro-suction structures, magnets or magneticattractive materials. The coupling features may interact with surfacesof corresponding couplings such as surfaces defining openings, see,e.g., FIGS. 7, 10, 14 , or surfaces such as a rim or other body surface,see, e.g., FIGS. 7-14 , configured to couple to magnetic attractivematerials or magnets of a coupling platform of an anchor device.

In addition to the above or in a further example, the projections of theembodiment illustrated in FIG. 19 comprise biased tabs. The tabs may bebiased outwardly of the perimeter of the body 92. For example, the tabsmay be biased by a spring. In some embodiments, the tabs may beretracted and extended by actuating a linkage (not shown) coupled to thetabs to assist in coupling the coupling platform to another couplingplatform in situ. In one example, a retainer may be used to maintain thetabs in a retracted position prior to coupling. A delivery device may beused to remove the retainer. In some embodiments, the retainer mayrelease the tabs outwardly in response to an environmental condition orqueue, which may include an induced electromagnetic or magnetic field,e.g., provided externally, by a delivery device, or by approximationwith magnets or transmitter associated with the other coupling platform,such as a with the corresponding coupling. Remote signaling, such asRFID may also be used to release the retainer is some embodiments.

The couplings 112 illustrated in FIGS. 15-19 include couplings 112generally positioned along the perimeter of the body 92 and that aregenerally aligned along a single cross-section, transverse to thelongitudinal axis of the implant device. In some embodiments, thecoupling platform 110 may include multiple rows of couplings 112,staggered couplings 112, or couplings 112 located at different positionsalong the longitudinal length of the body 92. For example, multipleflanges or rows of clips may extend around the perimeter of the body 92.Coupling platforms 110 may also include one or more rows of coupling 112that are positioned along different lengths of the body 92, such as aplurality of barbs arranged in a wave pattern around a perimeter of theanchor device, e.g., as described above with respect to FIG. 12 andbelow with respect to FIGS. 20A-22B.

Other coupling platform configurations may also be used. For example, acoupling platform may include a coupling comprising slot openings alonga rim to receive a corresponding coupling comprising a projection ofanother coupling platform. The projections may be received through theslot and then translated along a path within the slot. In oneembodiment, the slot may reduce in width or depth to achieve acompression fit. In another example, the slot may decrease in depth tocompress the projection and then increase in depth at a sub-slottherealong to allow decompression of the projection into the sub-slot tocouple the coupling platforms. In a further example, the projection isconfigured to be biased outwardly, such as the biased tabs describedabove with respect to FIG. 19 . In a further example, the slot providesa twist-fit. In any of the above or another embodiment, the projection,slot, or both may include magnets to attract and couple to thecorresponding coupling.

According to various embodiments, the anchor system includes a modularanchoring device. In one such embodiment, the anchor system alsoincludes an embedment device. The anchor system may include one or moreanchor devices wherein at least one of the anchor devices is configuredto couple or be attached to a medical device. The anchor system mayinclude a first anchor device configured to anchor to a tissue wall of alumen that is embedded with an embedment device. The first anchor devicemay include anchors, e.g., as described herein, that penetrate tissue,interact via magnetism with the embedment device within the tissue orfrom a tissue surface, or combination thereof. In one embodiment, thefirst anchor device includes or is attached to a medical device. Inanother embodiment, the anchor system includes a second anchor devicehaving a coupling platform configured to couple to a coupling platformof the first anchor device. The second anchor device may include,attach, or couple to a medical device. In a further embodiment, theembedment device includes a coupling platform and the first anchordevice includes a coupling platform configured to couple to the couplingplatform of the embedment device. The first anchor device may include,attach, or couple a medical device. In still a further embodiment, thefirst anchor device includes another coupling platform configured tocouple to a coupling platform of the second anchor device wherein thesecond anchor device is includes, attaches, or couples the medicaldevice. In any of the above embodiments, an anchor device may beconfigured to couple multiple anchor devices or medical devices. Forexample, an anchor device may couple a medical device utilizing acoupling platform described herein or may otherwise include variousfittings for attaching one or medical devices prior to implantation ofthe anchor device.

Embedment and anchor devices including coupling platforms describedherein may be configured for coupling, decoupling, or both in situ.Anchor devices may similarly be configured for anchoring to and removalfrom a tissue wall defining a biological lumen, which may be reinforcedwith an embedment device as described herein. Such configurations maybeneficially allow ease of removal, repair, and replacement of anchordevices and medical devices. In some embodiments, an anchor device andan associated coupling platform may provide a platform for coupling anddecoupling anchoring devices comprising medical devices on an as neededbased. In one example, coupling platforms comprising couplingconfigurations corresponding to a coupling platform of an anchor deviceor embedded device may be fitted to multiple medical devices. Thus,medical devices may be conveniently removed, implanted, and interchangedas needed.

In various embodiments, the anchor system includes an anchor deviceincluding a medical device configured to be delivered to the target sitetogether. In some embodiments, the anchor device and medical device areintegrated such that it may not be practical to detach the medicaldevice from the anchor device once implanted and anchored. For example,an integrated anchor and medical device may include a gastric bypasssleeve having an integrated anchor device comprising an inflatableballoon, e.g., such as described with respect to FIG. 13 wherein thesleeve may be sewn to or adhered with adhesive to the balloon.

FIG. 20A illustrates an embodiment of an anchor device 90 attached to amedical device 120 comprising a gastric sleeve 122 according to variousembodiments. The anchor device 90 has a body 92 including a rim 130having an annular cross-section an extending around a perimeter in awave conformation. The body 92 may be to that of the anchor devicedescribed with respect to FIG. 12 . For example, the rim may include awire, such as a stainless steel or nitinol wire. A plurality of anchors96 project from the rim 130. The anchors 96 may include projections,such as hooks, configured penetrate wall tissue reinforced with anembedded device to anchor thereto. For example, the embedded device maybe an embedded device described herein, such as a mesh stent, e.g., astainless steel or nitinol mesh stent, (see, e.g., FIG. 1 ), coil, e.g.,a stainless steel or nitinol coil, (see, e.g., FIG. 2 ), injectedpolymer, expandable tubing, or implanted threaded wires. In variousembodiments, the projections comprise barbs, hooks, or straightprojections. The rim 130 is attached to a proximal end 134 of the sleeve122. The sleeve 122 will typically comprise an impermeable material tomaintain separation between the interior and exterior of the sleeve 122.In one embodiment, the sleeve 122 comprises ePTFE, however, othermaterials may be used. In one particular embodiment, the sleeve 122comprises a 24 inch to 30 inch ePTFE impermeable sleeve. In otherembodiments, the sleeve 122 may be longer or shorter. The sleeve 122 mayattach to the body 92 of the anchor device 90 utilizing straps,adhesives, Velcro or other suitable method.

FIG. 20B illustrates the anchor device 90 and medical device 120 of FIG.20A implanted in a biological lumen according to one method. The anchordevice 90 and medical device 120 may be delivered into the esophagusutilizing a delivery device, which may be similar to the delivery devicedescribed with respect to FIG. 23 . For example, the anchor device 90and medical device 120 may be delivered endoscopically usingfluoroscopy. The distal end 126 of the sleeve 122 may be passed througha delivery sheath through the esophagus 136, stomach 138, and then bedelivered from the sheath into the duodenum 140. The anchor device 90and proximal end 124 of the sleeve 122 may be delivered from the sheathinto the esophagus 138. The anchor device 90 may include a deliveryconformation including a reduced dimension for delivery, which may besimilar to the delivery conformation described with respect to theembedment device. The anchor device 90 may transition or be manipulatedinto an anchor conformation at the target site 24. The anchors 96 mayanchor to a tissue wall at the target site 24, which is reinforced withan embedment device 10. In one embodiment, the delivery system includesa capsule that may be actuated, e.g., pulled back, to act as a plunger.The anchor device 90 may be positioned in the capsule in a collapseddelivery conformation. The sleeve 122 may be delivered over a guidewire. When fully extended in the intestines, the capsule may be pulledback into the esophagus, and the anchor device 90 may be pushed outusing the plunger, which may be actuated using a handle external to thepatient.

In some embodiments, multiple anchor devices may be integrated with amedical device. For example, FIG. 21A illustrates two anchor devices 90a, 90 b associated with a medical device 120 according to variousembodiments described herein. The medical device 120 includes a gastricbypass sleeve 122 having a first anchor device 90 a positioned along afirst end (proximal end 124) and a second anchor device 90 b positionedalong a second end (distal end 126). In some embodiments, the first orsecond anchor device 90 a, 90 b may be positioned along a middle portionof the sleeve 122. Additional anchor devices may also be used. The firstanchor device 90 a includes a body 92 a and is similar to the anchordevice described with respect to FIGS. 12 & 20A. The second anchordevice 90 b includes a body 92 b comprising a hollow cylinder or balloonsimilar to the anchor device described with respect to FIG. 13 .

FIG. 21B illustrates the anchor devices 90 a, 90 b and medical device120 of FIG. 21A implanted in a biological lumen according to one method.The anchor devices 90 a, 90 b and medical device 120 may be deliveredinto the esophagus utilizing a delivery device, which may be similar tothe delivery device described with respect to FIG. 23 . The distal end126 of the sleeve 122 including the second anchor device 90 b may bepassed through a delivery sheath extending through the esophagus 136,stomach 138, and then be delivered from the sheath into the duodenum140. The first anchor device 90 a and proximal end 124 of the sleeve 122may be delivered from the sheath into the esophagus 138. The secondanchor device 90 b may be inflated from a deflated delivery conformationto transition to an anchor conformation at the target site 24 b in theduodenum 140 resulting in outward force being applied against the tissuewall to thereby anchor the balloon. Thus, the application of outwardlydirected force against the tissue wall prevents retrograde passage intothe stomach. Additionally, in some embodiments, the configuration maynot apply significant outward force in the anchor conformation, e.g.,inflated, but does not permit retrograde passage into the stomach. Forexample, the anchor conformation may conform to one or more dimensionsof the duodenum or otherwise obtain dimensions larger than the pylorusto prevent retrograde passage into the stomach. The first anchor device90 a may transition or be manipulated into an anchor conformation at thetarget site 24 a. The anchors 96 may anchor to a tissue wall at thetarget site 24. In the illustrated embodiment, the tissue walls at bothtarget sites 24 a, 24 b are reinforced with a respective embedmentdevice 10 a, 10 b. In some embodiments, a second embedment device 10 bis not used.

In various embodiments, the sleeve 122 may be strengthened or otherwiseaugmented to maintain stable positioning when implanted. For example, asdescribed with respect to FIGS. 21A & B, additional anchor devices 90 bmay be employed to anchor multiple portions of the sleeve 122. Otheranchor devices 90, such as those described herein, may also be used toanchor to the duodenum. For example, an additional anchor device 90 bsimilar to the first anchor device 90 a may be added to the middle ordistal end of the sleeve 122 keep the sleeve 122 in the duodenum.

In some embodiments, passages for gastric acid or fluid may be formedthrough the sleeve 122, between the second anchor device 90 b and thewall of the duodenum, or between the second anchor device 90 b and thesleeve 122. For example, in various embodiments, a second anchor device90 b engages an embedment device 10 b or anchor device anchored alongthe embedment device 10 b to effectively couple thereto as describedherein. The second anchor device 90 b may anchor via projections such ashooks or other coupling platform that engages the tissue and embeddedstructure or a lumen projection thereof, which may include a couplingplatform of another anchor device anchored along the embedment device 10b. In one such embodiment, spaces between these anchor points mayprovide passage for gastric fluid. For example, passages for gastricfluid may be provided between the second anchor device 90 b and ananchor device to which it is anchored, the embedment device 10 b and alumen projection thereof, the second anchor device and the embedmentdevice 10 b, or the embedment device 10 b and an anchor device to whichthe second anchor device 90 b is anchored. In one embodiment, the secondanchor device 90 b or an anchor device to which it is anchored definespassages for gastric fluid.

FIG. 22A illustrates an anchor device 90 and medical device 120according to various embodiments. The anchor device 90 and medicaldevice 120 are similar to that described with respect to FIGS. 20A &20B; however the bypass sleeve includes an embedded wire 150 extendingalong the sleeve 122. The wire 150 may comprise a metal or alloy such asstainless steel or nitinol. The wire 150 is fixed within the sleeve 122and may be manipulated to a desired conformation to strengthen thestability and conformation of the sleeve 122. In a further embodiment, awire 150 may be deployed with the sleeve 150 and subsequently ratchetedor snapped into place similar to a zip tie. In another embodiment, thewire 150 comprises a stiffing coil wire that coils around the sleeve122. In yet another embodiment, the sleeve 122 may have embedded wire150 comprising a plurality of rings. In still yet another embodiment,the sleeve 122 includes an embedded wire 150 comprises a stiffing coilconfigured to provide modification capabilities similar to corrugatedtubing.

FIG. 22B illustrates the anchor device 90 and medical device 120 of FIG.22A implanted in a biological lumen according to one method. The anchordevice 90 and medical device 120 may be delivered into the esophagusutilizing a delivery device as described with respect to FIG. 20B. Thestiffening wire 150 may be used to position or maintain position of thedistal end 126 of the sleeve 122 within the duodenum 140.

While the illustrated anchor devices 90 generally include annular bodiesthat anchor or couple to the tissue or coupling platforms along multiplearcs forming the circumference of the wall, device, or lumen, in someembodiments, anchor devices 90 may attach to a tissue wall, device, orlumen only along a 15, 45, 90, or 180 arch. For example, an anchordevice 90 may include any cross-sectional shape and may or may notinclude a central hole. An anchor device 90 may attach to or couplealong only a portion of a circumference of the lumen.

It is to be appreciated that the anchor devices illustrated in FIGS.9-14 may be configured with similar coupling platforms as described withrespect to FIGS. 15-19 to couple to another coupling platform ratherthan anchor to a tissue wall, embedment device, or another anchor deviceanchored to a tissue wall or embedment device. It is also to beappreciated that the anchor devices illustrated in FIGS. 9-14 may alsoinclude medical devices in addition to or instead of coupling withcoupling platforms of anchor devices comprising medical devices or thatmay further couple with anchor devices comprising medical devices.Further, the anchor devices 90 illustrated in FIGS. 15-22B may furtherinclude coupling platforms to also couple additional anchor devices. Itis also to be appreciated, that coupling platforms described withrespect to coupling two particular devices may be switched.

In various embodiments, the anchor device may produce an outwardlydirected force against a reinforced tissue wall to assist in engagementof anchors or force driven anchoring. As noted above and elsewhereherein, the embedment device may prevent the reinforced wall fromexpanding away from outwardly directed force applied along thereinforced wall. The reinforced wall may provide a firm structure ontowhich the outwardly directed force may compress against to anchor alongthe reinforced wall. In one embodiment, an embedment device may beconfigured to provide different or differential rigidity to outwardlydirected force. For example, the embedment device may include acontoured mesh or coil providing an area of reduced diameter compared toan adjacent reinforced area. In another example, an amount of polymerinjected along a portion of the tissue wall is reduced relative to oneor more adjacent regions. In another example, a depth or expandabilityof wire threaded along the tissue wall may be increased relative to oneor more adjacent regions. In one example, the embedment device may bedifferentially expanded outwardly a distance that does not result inmigration if the embedment device external of the tissue wall but thatallows a pocket or groove to form along the wall into which an anchor orcoupling thereof may position within. The pocket or groove may extendabout an entire circumference of the wall or only along one or moreportions thereof. In some embodiments, an anchor of an anchor device mayposition just proximal to the reinforced portion of the wall such thatthe outwardly directed force expands the wall outward relative to thereinforced portion of the wall. In one embodiment, the embedment deviceor devices may be embedded at two or more locations along the wall andtherein provide a reinforced wall at the two or more locations. Ananchor may be located between the two or more locations andthere-between provide outwardly directed force to anchor along thereinforced wall between the two or more embedment devices or regionsthereof. In some embodiments, the embedment device is flexible withrespect to reduction in cross section to allow contraction of the tissuewall but rigid with respect to dilation beyond a maximum cross-sectionor perimeter, as described above with respect to limitation ofmigration. A positioning device may be used to embed a flexibleconfiguration of an embedment device. Assisting embedment may alsoinclude heat, electrical current, wire shapes, or other embedmentassisting features described herein.

In some embodiments, an embedment device may be deployed within thelumen while coupled to a medical device. For example, a medical devicemay be coupled to the embedment device by an attachment mechanism. Insome embodiments, the attachment mechanism is removable such that themedical device and embedment device may be detached after deployment.For example, the medical device and embedment device may be attached viaan attachment device comprising a zipping release system or otherrelease system. In various embodiments, the coupling attachment may bepermanent such that the medical device may be removed only when removedalong with the embedment device or by cutting or removing an attachmentstructure that couples the embedment device and the medical device. Forexample, as introduced above and elsewhere herein, some embodiments mayinclude an embedment device that is integral with that of a medicaldevice to provide anchorage within the gastrointestinal tract.

FIG. 34 illustrates an example of an anchoring system 2 for anchoring amedical device 120 within a gastrointestinal tract lumen. The system 2includes a medical device 120 comprising an embedment device 10. Themedical device 120 is shown to include a gastric bypass stent, similarto FIGS. 15-22B, having an embedment device 10 attached along aproximately end 124. The embedment device 10 may be configured to embedwithin a wall of the esophagus, for example. The embedment device 10 maybe attached to the medical device 120 by one or more connectors 121 andinclude a body 12. The body 12 may include an embedment structurepositioned outward of the medical device 120 configured to embed atissue wall. In some embodiments, the embedment structure may be biasedoutwardly to apply force on a tissue wall. In the illustratedembodiment, the embedment structure comprises a wire mesh that positionsoutward of the medical device 120. The illustrated wire mesh comprises acontinuous annular cross-section and a tubular shape. In otherembodiments, the embedment structure may comprise a wire mesh or otherstructure that positions outwardly of the medical device and isdiscontinuous. For example, one, two, three, or more structures mayposition outwardly for embedding into the tissue wall. In someembodiments, the embedment structure may be biased to expand outwardlyto increase an outer diameter of the body 12. For example, a firstembedment structure and a second embedment structure or a firstembedment structure and a support structure, e.g., a structureconfigured to compress against by not puncture or embed a tissue wall,may be positioned on approximately opposite sides of a perimeter of thebody and each be biased in approximately opposite directions. Forinstance, one or more connectors 121 may be biased or extendable to urgethe structures outwardly. In the illustrated embodiment, the wire meshis expandable to a diameter larger than a diameter of a lumen the body12 is configured to embed to assist in embedding the body 12. In oneexample, one or more connectors 121 are outwardly biased or extendableto increase the diameter of the wire mesh to assist in embedding thebody 12. In one configuration, the system 2 includes a switch operableto outwardly bias the body, e.g., trigger one or more connectors toextend outwardly to outwardly expand the body. In some embodiments, thewire mesh is biased toward a larger diameter than a lumen it is toembed.

In some embodiments, the medical device may include an embedment device10 that is configured to embed within the gastrointestinal tract at aposition more proximal or distal than the body of the medical device 120with respect to the oral cavity. For example, one or more connectors,such as wires or other structures, may attach between the embedmentdevice 10 and the body of the medical device 120. In some embodiments,the medical device 120 may include additional embedment devices 10positioned to embed tissue walls to anchor the medical device 120 withinthe gastrointestinal tract. For example, a second embedment device maybe positioned along, near, or distal of, the distal end 126 of thesleeve 122 for embedding within the duodenum.

While FIG. 34 illustrates a mesh embedment device configuration, it isto be appreciated that medical devices 120 may include any embedmentdevice 10 described herein. Similarly, while the medical device 120 isillustrated as a bypass sleeve, any medical device for fixation withinthe gastrointestinal tract may be utilized, such as medical devices thatregulate or modify flow of material within the lumen, detect or analyzecomponents of material within the lumen, release substances into thelumen such as medications or other therapeutic substances, or observe ormeasure conditions or state within the lumen.

In various embodiments, a method to reinforce a biological lumen, suchas the gastrointestinal tract, includes embedding an embedment devicecomprising a reinforcing material or structure into an area of a tissuewall defining the lumen. The method may include embedding the embedmentdevice in a manner so as to prevent expansion or otherwise strengthenthe wall. The method may include delivering or embedding the embedmentdevice endoscopically. Delivering or embedding the embedment device mayinclude injecting a polymer, threading a wire or wires, or applying ordelivering a device to apply outward force from within the lumen tocause wires or a mesh structure to embed via the outward force.

In various embodiments, the embedment device may be used to reinforce atissue wall of a biological lumen. As described above and elsewhereherein, the reinforced tissue wall may therefore be strengthened forsubsequent anchoring of devices. For example, the embedment device maybe used to strengthen a tissue wall to allow anchoring devices, whichmay include implant devices, in the gastrointestinal tract for variousreasons, including diagnostic, slow or speed transit, or bypass areas.In further embodiments, the embedment device may be used to reinforce astomach from expanding after gastric reduction surgery, preventingesophageal dilation in patients with Achalasia. The reinforcement maystrengthen the reinforced area to withstand peristaltic and other forcesdragging on an implant anchored thereto. The embedment device may befurther configured to allow or facilitate coupling, anchoring, or both.

Anchor devices for anchoring to the reinforced gastrointestinal tractmay anchor via anchor mechanisms described herein. For example, anchordevices may anchor to a reinforced gastrointestinal tract via directforce. That is, the embedment device may prevent or limit the ability ofthe tissue walls along the reinforced portion of the lumen to expandaway from the direct, outward, force. In one example, the anchor devicemay include magnets providing magnetic attraction to the embedmentdevice where the embedded structure allows for stronger forces to beapplied than the native structure could resist.

According to various embodiments, a method of reinforcing a biologicallumen comprises positioning an embedment device at a target site whereinthe embedment device applies outwardly directed force against a tissuewall defining the lumen. The embedment device may embed within thetissue wall. The embedment device may by implanted utilizing endoscopictechniques.

As noted above, the anchor system may be used to provide long-termanchorage and/or long-term reinforcement of the gastrointestinal tract.That is, the anchor system may be used as an anchor point for thechronic implantation and anchorage of medical devices to a reinforcedtissue wall. If it is desirable to remove the embedment device, variousremoval techniques may be used. For example, a covered stent, balloon,or other surface may be compressed against the lumen wall into which theembedment device is embedded to cause pressure ischemia with respect tothe intervening tissue for a sufficient period of time to result in thedestruction of the intervening tissue or dislodgement of the embedmentdevice, e.g., via pushing or cutting through the tissue. In variousembodiments, pressure may be applied for minutes or hours, e.g., betweenapproximately 30 seconds and approximately 5 minutes, betweenapproximately 5 minutes and approximately 10 minutes, betweenapproximately 10 minutes and approximately 20 minutes, betweenapproximately 10 minutes and approximately 30 minutes, betweenapproximately 20 minutes and approximately 50 minutes, betweenapproximately 30 minutes and approximately 60 minutes, betweenapproximately 60 minutes and approximately 90 minutes, betweenapproximately 60 minutes and approximately 2 hours, betweenapproximately 2 hours and approximately 5 hours, between approximately 5hours and approximately 12 hours, between approximately 12 hours andapproximately 24 hours, or approximately 1 day or longer. In variousembodiments, the length of time pressure is applied to the embeddedtissue may consider diameter of the embedded structure, amount ofpressure applied, and scarring. Greater pressure will typically resultin quicker destruction of the tissue or dislodgement of the embedmentdevice from the tissue wall. The destruction or cutting of theintervening tissue or pushing out of the embedment device allows removalof the embedment device. In one procedure, a balloon is inflated withinthe lumen along the embedded portion of the tissue wall to a largerdiameter than the current diameter of the lumen to apply pressureagainst the tissue wall. Inflation of the balloon increases a diameterof the balloon within the lumen to a larger diameter than the normaldiameter of the lumen and applies outwardly directed pressure againstthe lumen wall to cause pressures ischemia, leading to destruction ofthe tissue between the embedment device and the balloon, pushing out ofthe embedment device from the tissue wall, and/or the embedmentstructure cutting through the tissue. In one example, the balloon isinflated to apply pressure for minutes or hours as described above.

In some embodiments, the embedment device includes a portion that doesnot embed and that may be used to assist in removal. The unembeddedportion may include a projection positioned to extend into the lumenwhen the embedment device is embedded. In one example, the projectionmay comprise a coupling for coupling an anchor device and/or medicaldevice to the embedment device. In one embodiment, a portion of theembedment device is covered such that it does not embed tissue and maybe used to grasp to assist in removal of the embedment device. Forexample, a mesh embedment device may have a covering along an endconfigured to remain within the interior of the lumen along the tissuewall when the embedment portion embeds. In one configuration, thecovered portion comprises about a 5 mm to about a 1 cm length of theembedment device, although other lengths may be used.

Therefore, for anchorage purposes, structures or medical devices coupledto the embedment device should not completely overlap the embeddeddevice while applying sufficient outward directed pressure to causepressure ischemia for a period of time sufficient to dislodge theembedment device and/or to destroy the mucosal and/or smooth muscletissue into which the embedment device embeds.

Numerous specific details are set forth herein to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. It will be understood by those skilled in theart, however, that the embodiments may be practiced without the specificdetails described and illustrated herein. In other instances, well-knownoperations, components, and elements have not been described in detailso as not to obscure the embodiments described in the specification.Those of ordinary skill in the art will understand that the embodimentsdescribed and illustrated herein are non-limiting examples, and thus itcan be appreciated that the specific structural and functional detailsdisclosed herein may be representative and do not necessarily limit thescope of the embodiments, the scope of which is defined solely by theappended claims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “in a further embodiment,” “one embodiment,” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in variousembodiments,” “in some embodiments,” “in a further embodiment,” “in oneembodiment,” or “in an embodiment” in places throughout thespecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments. Thus, theparticular features, structures, or characteristics illustrated ordescribed in connection with one embodiment may be combined, in whole orin part, with the features, structures, or characteristics of one ormore other embodiments without limitation.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.Any numerical range recited herein includes all values from the lowervalue to the upper value. For example, if a range is stated as 1 to 50,it is intended that values such as 2 to 40, 10 to 30, or 1 to 3, etc.,are expressly enumerated in this specification. These are only examplesof what is intended, and all possible combinations of numerical valuesbetween and including the lowest value and the highest value enumeratedare to be considered to be expressly stated in this application. Withrespect to numerical descriptions modified by approximately, themodified number is intended to include +/- 10% of the identified number.Unless expressly stated to the contrary, “or” refers to an inclusive orand not to an exclusive or. For example, a condition A or B is satisfiedby any one of the following: A is true (or present) and B is false (ornot present), A is false (or not present) and B is true (or present),and both A and B are true (or present). In addition, use of the “a” or“an” are employed to describe elements and components of the embodimentsherein. This is done merely for convenience and to give a general senseof the description. This description, and the claims that follow, shouldbe read to include one or at least one and the singular also includesthe plural unless it is obvious that it is meant otherwise.

What is claimed is:
 1. A method of providing chronic anchorage within agastrointestinal tract lumen, the method comprising: embedding a body ofan embedment device within a portion of a tissue wall defining agastrointestinal tract lumen, wherein the embedment device comprises oneor more structures extending from the body to position within the lumenwhen the body is embedded within the tissue wall, and wherein the one ormore structures comprise a coupling platform configured to couple to acorresponding coupling platform of an anchor device in situ to anchorthe anchor device within the lumen.
 2. The method of claim 1, whereinembedding the body comprises applying outwardly directed force along aninterior side of the tissue wall to embed the body therein.
 3. Themethod of claim 2, wherein applying the outwardly directed force alongan interior side of the tissue wall comprises compressing the bodyagainst the interior side of the tissue wall.
 4. The method of claim 2,wherein the body of the embedment device has a cross-section dimensiongreater than an initial corresponding cross-section dimension of thelumen to therein apply the outwardly directed force along the interiorside of the tissue wall to embed therein.
 5. The method of claim 4,wherein the cross-section dimension of the body is less than acorresponding cross-section dimension of the tissue wall andcorresponding lumen, taken from exterior sides of the tissue wall, suchthat the body does not migrate to an exterior side of the tissue wall.6. The method of claim 1, wherein the body comprises a wire mesh, andwherein the wire mesh includes one or more physical blocks extendingover one or more openings within the mesh to prevent migration of thebody to an exterior side of the tissue wall.
 7. The method of claim 1,wherein the body comprises an arcuate perimeter.
 8. The method of claim1, wherein the body comprises a wire and embedding the body comprisesthreading the wire through the tissue wall.
 9. The method of claim 1,wherein the body comprises a polymer and embedding the body comprisesinjecting the polymer into the tissue wall.
 10. The method of claim 1,wherein the body comprises a tubular structure, wherein the tubularstructure is expandable or biased to obtain a cross-section dimensiongreater than an initial corresponding cross-section dimension of thelumen to therein apply outwardly directed force along the interior sideof the tissue wall to embed therein.
 11. The method of claim 10, whereinthe tubular structure comprises a wire mesh or coil.
 12. The method ofclaim 1, wherein one or more dissolvable or absorbable barbs, hooks, orpins extend from the body to assist in stabilizing the body prior to orduring embedding.
 13. The method of claim 1, wherein the couplingplatform comprises one or more couplings configured to couple tocorresponding couplings of the corresponding coupling platform.
 14. Themethod of claim 13, wherein the one or more couplings comprise a magnet,magnetic attractive material, hook, latch, clip, loop, rail, groove,adhesive, or combination thereof.
 15. The method of claim 1, wherein theanchor device comprises a medical device and the method furthercomprising coupling a medical device to the coupling platform in situ.16. The method of claim 15, further comprising decoupling the anchordevice from the coupling platform in situ.
 17. The method of claim 16,further comprising re-coupling the medical device to the couplingplatform in situ or coupling another medical device to the couplingplatform in situ.
 18. A method of anchoring a medical device withingastrointestinal tract lumen, the method comprising: delivering amedical device within a gastrointestinal tract lumen proximal to acoupling platform, wherein the coupling platform comprises one or morecoupling structures positioned within the lumen configured to couple toone or more coupling structures positioned on or extending from themedical device, and wherein the coupling platform is attached or coupledto a body of an embedment device embedded in a portion of a tissue walldefining the lumen; and coupling the one or more coupling structures ofthe medical device to the one or more coupling structures of thecoupling platform to anchor the medical device within the lumen.
 19. Ananchoring system for anchoring a medical device within agastrointestinal tract lumen, the system comprising: a medical devicecomprising a gastric bypass sleeve; and an embedment device positionedat a proximal end of the gastric bypass sleeve, the embedment devicecomprising a body configured to embed a tissue wall defining agastrointestinal lumen, wherein the body comprises a wire meshpositioned along an outer perimeter of the body that is biased outwardlyto increase a diameter of the outer perimeter of the body.
 20. Theanchor device of claim 19, wherein the wire mesh has a tubular shape andextends continuously along the perimeter.